The use of antiretrovirals (ARVs) in combination for treating patients with HIV has greatly ameliorated morbidity and mortality by reducing viral load to undetectable levels and boosting the body’s immunity. However serious adverse reactions causing long- or short-term effects have been associated with ARV treatment. These reactions have caused major concerns internationally, potentially threatening patient adherence to long-term treatment. The duration of treatment of patients infected with HIV; co-morbid conditions, such as tuberculosis (TB) and malaria; and the complications due to HIV infection or AIDS make it difficult to determine the exact cause of the adverse events (AEs) experienced by patients taking ARV medicines. The prevalence of co-morbid conditions differs across socioeconomic groups and geographical regions, which may contribute to differences in ARV toxicity profiles. Hence, it is recommended that national HIV treatment programs establish population-level ARV toxicity profiles for their countries. Therefore, with increased survival of patients and the long-term duration of antiretroviral treatment (ART), it is important for national pharmacovigilance centers to monitor the immediate and long-term effects of these ARVs on the population. A simple, practical, and cost-effective method for evaluating the safety of drugs approved for human use is the spontaneous reporting of AEs to a pharmacovigilance center. This method is helpful for identifying serious and rare medicine-associated AEs. The evaluation of these AEs informs regulatory decisions on improving the safety of medicines in the country and globally. The objective of the Analysis of Namibia Therapeutics Information and Pharmacovigilance Centre’s Data was to identify drug safety concerns associated with the use of antiretroviral medicines in Namibia’s HIV treatment program, by analyzing pharmacovigilance data generated from spontaneous reports of suspected adverse events (AEs).
Archive | TuberculosisRSS feed for this section
Therapeutics Information and Pharmacovigilance Centre’s Analysis of Spontaneous Adverse Events due to Antiretroviral and Other Medicines
SIAPS final report showcases achievements across 46 countries. Interventions are described by intermediate results and health areas and demonstrate how SIAPS successfully worked with a range of stakeholders, including Ministries of Health, to bolster pharmaceutical systems and address country-specific needs.
USAID-SIAPS Technical Assistance to NTP Laboratory Network: Strengthening Leadership, Management, and Governance Capacity
The National Tuberculosis Program’s strategic direction for the laboratory services is to improve access to laboratory services so that all high-risk TB patients are tested using World Health Organization (WHO)-endorsed rapid diagnostic tests (RDTs) as the initial diagnostic procedure, particularly the Xpert MTB/RIF assay (Xpert). This entails the strengthening of the laboratory network (LNW) and its support systems to achieve a wider deployment and implementation of RDTs while ensuring the sustained delivery and quality of all currently employed TB diagnostic technologies, including smear microscopy, culture and drug susceptibility testing (DST), and line probe assay (LPA). To facilitate the laboratory network strengthening processes, SIAPS focused its technical assistance in strengthening the leadership, management, and governance (LMG) capacity of NTP, particularly the National Tuberculosis Reference Laboratory (NTRL), since the latter is mandated to provide technical leadership and oversight to the management of the laboratory network.
2017 Regional Planning Workshop for Laboratory Network Strengthening: Expansion of Rapid TB Diagnostic Laboratories and Strengthening EQA-DSSM Implementation
The National TB Reference Laboratory (NTRL) organized two planning workshops to assist the 17 Department of Health (DOH) regional NTP teams in developing their action plans for the expansion of the rapid TB diagnostic laboratories (RTDLs) and for strengthening the laboratory systems. The objectives of the workshop were to assist the regional NTP teams in analyzing the situation of the laboratory network in their respective areas and in developing a regional plan for the expansion of RTDLs and for strengthening external quality assessment (EQA) implementation. SIAPS provided technical assistance to the NTRL with workshop preparations and in facilitating discussions.
NTP Laboratory Network Assessment: Strategic Directions to Improve Access and Quality of TB Diagnostic Services Assessment Report
The National TB Program has embarked on the new Philippine Strategic TB Elimination Plan Phase One: 2017–2022, setting targets and objectives to significantly reduce TB mortality and prevalence by 2022. Among the key activities in the plan is to ensure the access of all priority patients to rapid TB diagnosis along with drug susceptibility testing for rifampicin. This entails the expanded deployment of the new RDTs, exemplified by Xpert, at the primary level of care. The NTP envisions using RDTs as the initial TB diagnostic test within the short term. This assessment was done to gather information on the laboratory network’s capacity to provide access to diagnostic services, particularly the new rapid TB diagnostics at the primary level of care, identify factors that serve as barriers to ensuring the provision of continuous and reliable laboratory services, and to propose actions to address the identified barriers.
SIAPS Final Report showcases achievements across 46 countries. Interventions are described by intermediate results and health areas and demonstrate how SIAPS successfully worked with a range of stakeholders, including Ministries of Health, to bolster pharmaceutical systems and address country-specific needs.
The primary goal of the SIAPS TB Core portfolio was to ensure the availability of quality pharmaceutical products and support the implementation of effective pharmaceutical services for achieving global and the United States Government TB program targets; also represented in the United States Government health goals were protecting communities against infectious diseases, fostering an AIDS-free generation, and strengthening health systems.
The Department of Health-Pharmaceutical Division (DOH-PD) and National TB Program (NTP) in the Philippines adopted the web‐based application Pharmacovigilance Monitoring System (PViMS) to ensure systematic data collection and simplify the analysis of medicine safety information. PViMS is a free web tool developed by SIAPS to help clinicians, regulatory bodies, and implementing partners monitor medicine safety, specifically in resource-limited countries. The SIAPS Program works to improve the availability and quality of information for decision making through the use of electronic tools combined with systems strengthening.
A multicountry user experience analysis of e-TB Manager and an in-depth study in Ukraine were published. However, the procedural aspects of e-TB Manager implementation in each country were not documented. While facilitators and barriers for eHealth implementation in resource-constrained settings are well known, the objective of this paper is to summarize the tailored implementation approaches given local context, which is a crucial consideration. The paper summarizes the key lessons learned and implications for other electronic health information systems.
Theresia Cloete was diagnosed with tuberculosis (TB) in 2002. She was put on treatment but after four months stopped taking her TB medication. Last year, she was diagnosed with drug-resistant TB. Like Cloete, many TB patients stop taking their life-saving medication before they are cured. She is now one of eight in-patients waiting for stabilization […]
Project dates: 2011-2016
The end use verification (EUV) survey was conducted on December 21-30, 2017, in the departments of Zou and Collines. The […]
Project dates: 2012-2018