Sentinel site active surveillance of safety of first-line antiretroviral medicines in Namibia.

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 naïve 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 © 2016 John Wiley & Sons, Ltd.

Implementing an Integrated Pharmaceutical Management Information System for Antiretrovirals and Other Medicines: Lessons From Namibia.

The success of the Namibian government's "treatment for all" approach to control and stop the country's HIV epidemic is dependent on an uninterrupted supply of antiretrovirals (ARVs) for people living with HIV. The public health system in Namibia, however, was constrained by an inefficient paper-based pharmaceutical information system resulting in unreliable and inaccessible data, contributing to persistent stock-outs of ARVs and other essential pharmaceuticals. This article describes the incremental implementation of an integrated pharmaceutical management information system to provide timely and reliable commodity and patient data for decision making in Namibia's national antiretroviral therapy (ART) program and the Ministry of Health and Social Services (MoHSS). The system has 4 interlinked information tools: (1) the Electronic Dispensing Tool (EDT) that manages the dispensing and inventory of antiretrovirals at service delivery points; (2) the EDT national database, which facilitates the flow, storage, and collation of ART data at the central level; (3) the Facility Electronic Stock Card used to manage pharmaceutical stocks and report inventory movement data to the national level; and (4) the Pharmaceutical Management Information Dashboard that integrates all 3 tools plus the warehouse management tool used by the central and regional medical stores into 1 dashboard that serves as a platform for the analysis and dissemination of pharmaceutical information throughout the health system. Implementing the pharmaceutical management information system was a prolonged and complicated process, with key challenges related to user acceptance and human resource constraints. The integrated pharmaceutical management information system enables Namibia to collect more than 90% of transactional commodity and patient dispensing data from more than 85% of all ART sites. Health managers use information from the system for medicine quantification decisions and to improve pharmaceutical service delivery. The MoHSS and its partners in the national ART program use the information for monitoring the World Health Organization early warning indicators for HIV drug resistance; ART defaulter tracing; and for planning, reporting, and research purposes. Namibia's pharmaceutical management information system demonstrates the feasibility and benefits of integrating related tools while maintaining their specialized functionality to address country-specific information and inventory management needs.

Digital health technologies to support access to medicines and pharmaceutical services in the achievement of sustainable development goals.

OBJECTIVES: The objective of this study was to describe the conceptual and implementation approach of selected digital health technologies that were tailored in various resource-constrained countries. To provide insights from a donor-funded project implementer perspective on the practical aspects based on local context and recommendations on future directions. METHODS: Drawing from our multi-year institutional experience in more than 20 high disease-burden countries that aspire to meet the 2030 United Nations Sustainable Development Goal 3, we screened internal project documentation on various digital health tools that provide clarity in the conceptual and implementation approach. Taking into account geographic diversity, we provide a descriptive review of five selected case studies from Bangladesh (Asia), Mali (Francophone Africa), Uganda (East Africa), Mozambique (Lusophone Africa), and Namibia (Southern Africa). FINDINGS: A key lesson learned is to harness and build on existing governance structures. The use of data for decision-making at all levels needs to be cultivated and sustained through multi-stakeholder partnerships. The next phase of information management development is to build systems for triangulation of data from patients, commodities, geomapping, and other parameters of the pharmaceutical system. A well-defined research agenda must be developed to determine the effectiveness of the country- and regional-level dashboards as an early warning system to mitigate stock-outs and wastage of medicines and commodities. CONCLUSION: The level of engagement with users and stakeholders was resource-intensive and required an iterative process to ensure successful implementation. Ensuring user acceptance, ownership, and a culture of data use for decision-making takes time and effort to build human resource capacity. For future United Nations voluntary national reviews, countries and global stakeholders must establish appropriate measurement frameworks to enable the compilation of disaggregated data on Sustainable Development Goal 3 indicators as a precondition to fully realize the potential of digital health technologies.

Active Surveillance versus Spontaneous Reporting for First-Line Antiretroviral Medicines in Namibia: A Cost-Utility Analysis.

INTRODUCTION: Active surveillance pharmacovigilance is a systematic approach to medicine safety assessment and health systems strengthening, but has not been widely implemented in low- and middle-income countries. This study aimed to assess the cost effectiveness of a national active surveillance pharmacovigilance system for highly active antiretroviral therapy (HAART) compared with the existing spontaneous reporting system in Namibia. METHODS: A cost-utility analysis from a governmental perspective compared active surveillance pharmacovigilance to spontaneous reporting. Data from a sentinel site active surveillance program in Namibia from August 2012 to April 2013 was projected to all HIV-infected adults initiating HAART in Namibia. Costs (pharmacovigilance program, HAART, adverse event [AE] treatment), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs, dollars/QALY) were evaluated. Analysis was completed for (i) cohort analysis: a single cohort beginning HAART in 1 year in Namibia followed over their remaining lifetime, and (ii) population analysis: patients continued to enter and leave care and treatment over 10 years. RESULTS: For the cohort analysis, totals were US$21,267,902 (2015 US dollars) and 116,224 QALYs for care and treatment under active surveillance pharmacovigilance versus US$15,257,381 and 116,122 QALYs for care and treatment under spontaneous reporting pharmacovigilance, resulting in an ICER of US$58,867/QALY for active surveillance compared with spontaneous reporting pharmacovigilance. The population analysis ICER was US$4989/QALY. Results were sensitive to quality of life associated with AEs. CONCLUSION: Active surveillance pharmacovigilance was projected to be highly cost effective to improve treatment for HIV in Namibia. Active surveillance pharmacovigilance may be valuable to improve lives of HIV patients and more efficiently allocate health resources in Namibia.

Assessment of the World Health Organization's HIV Drug Resistance Early Warning Indicators in Main and Decentralized Outreach Antiretroviral Therapy Sites in Namibia.

BACKGROUND: The World Health Organization (WHO) early warning indicators (EWIs) of HIV drug resistance (HIVDR) assess factors at individual ART sites that are known to create situations favourable to the emergence of HIVDR. METHODS: In 2014, the Namibia HIV care and treatment program abstracted the following adult and pediatric EWIs from all public ART sites (50 main sites and 143 outreach sites): On-time pill pick-up, Retention in care, Pharmacy stock-outs, Dispensing practices, and Viral load suppression. Comparisons were made between main and outreach sites and between 2014 and 2012 using the Wilcoxon signed-rank test in a matched analysis. RESULTS: The national estimates were: On-time pill pick-up 81.9% (95% CI 81.1-82.8) for adults and 82.4% (81.3-83.4) for pediatrics, Retention in care 79% retained on ART after 12 months for adults and 82% for pediatrics, Pharmacy stock-outs 94% of months without a stock-out for adults and 88% for pediatrics, and Dispensing practices 0.01% (0.001-0.056) dispensed mono- or dual-therapy for adults and 0.01% (0.001-0.069) for pediatrics. Viral load suppression was significantly affected by low rates of Viral load completion. Main sites had higher On-time pill pick-up than outreach sites for adults (p<0.001) and pediatrics (p<0.001), and no difference between main and outreach sites for Retention in care for adults (p = 0.761) or pediatrics (p = 0.214). From 2012 to 2014 in adult sites, On-time pill pick-up (p = 0.001), Retention in care (p<0.001), and Pharmacy stock-outs (p = 0.002) worsened. In pediatric sites, On-time pill pick-up (p<0.001) and Pharmacy stock-outs (p = 0.012) worsened. CONCLUSIONS: Results of EWIs monitoring in Namibia provide evidence about ART programmatic functioning and contextualize results from national surveys of HIVDR. These results are worrisome as they show a decline in program performance over time. The national ART program is taking steps to minimize the emergence of HIVDR by strengthening adherence and retention of patients on ART, reducing stock-outs, and strengthening ART data quality.