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 | Health AreasRSS feed for this section
Therapeutics Information and Pharmacovigilance Centre’s Analysis of Spontaneous Adverse Events due to Antiretroviral and Other Medicines
SIAPS worked with global and in-country partners to improve access to and use of life-saving medicines for women and children, thereby contributing to ending preventable child and maternal deaths. By promoting a pharmaceutical systems strengthening approach, SIAPS activities went beyond addressing supply chain challenges to incorporate interventions to positively affect the system as a whole, from strengthening pharmaceutical legislation, regulations, and policies to supporting appropriate community case management (CCM) and patient-centered care. SIAPS strategies that were implemented at the global and country levels included improving governance of pharmaceutical systems, strengthening supply chain management (SCM) capacity, increasing the availability of pharmaceutical information for decision making, developing appropriate pharmaceutical financing strategies, and promoting rational use of medicines and supplies.
Guidelines and Standard Operating Procedures for the Supply Chain Management of Drugs Used in Mass Drug Administration of Neglected Tropical Disease Programs
One of the constraints to effective control of neglected tropical diseases (NTDs) is that the needed medicines are often not available in sufficient quantities at service delivery points at the time of scheduled mass drug administration (MDAs). Supply systems for NTD drugs (NTDDs) differ from those for most other essential medicines in that NTDDs need to be delivered to selected endemic target sites on a defined schedule based on the frequency of the MDA, which could be once or twice a year. Consequently, NTDD supply chain systems need to be well designed and efficiently managed to ensure that health workers and communities have access to NTDDs and supplies, such as registers, medicines for managing adverse drug reactions (ADRs), height measuring poles, etc., at time of MDA. Availability of these items may be influenced by a variety of factors, including availability of the supplies at the central level, poor stock control, provider experience, economic influences, and transport. This guidance and standard operating procedures (SOPs) document will be valuable additional material for anyone who manages NTDDs—from program managers to service providers, community health workers (CHWs), community drug distributors (CDDs), teachers, technical assistance providers, and public- and private-sector partners. This document describes how to properly manage NTDD supplies throughout the supply chain and distribution process. The guidelines and SOPs serve as a reference document that NTD programs can use to review and enhance their own procedures for managing NTDDs and develop or refine their own SOPs to support the proper implementation of the supply chain components of MDA. These guidelines and SOPs are based on the assumption that countries already have the systems, structures, and processes in place to implement MDAs for NTDs.
Keep Maternal, Newborn, and Child Health Medicines Safe: Introducing MNCH commodities into a pharmacovigilance system
As countries aim to achieve the Sustainable Development Goals, there is an emphasis on increasing the availability of medicines. However, poor quality products or dispensing methods may decrease treatment effectiveness or even result in patient death. ADEs negatively affect patient care and increase costs to the system. A functioning PV system monitors these events and triggers actions to minimize their impact. While some disease-specific areas, such as tuberculosis, have made PV a regular tenant of their treatment programs, medicines used for maternal, newborn, and child health (MNCH) are often ignored in reporting. This case study highlights steps taken to ensure the safe use of medicines for mothers, newborns, and children through regular adverse drug event (ADE) reporting as part of the national pharmacovigilance (PV) program in Bangladesh.
L’objectif de l’outil OSPSANTE est de capturer, de suivre, d’agréger et de diffuser des informations sur les produits de Nutrition et de lutte contre le paludisme, la PF, la SMI et le VIH, pour soutenir la prise de décision basée sur des éléments de preuve au Mali. L’outil OSPSANTE aidera le pays et les organisations internationales, telles que l’USAID, l’ONUSIDA, l’OMS, le Fonds mondial et autres parties prenantes à améliorer les prévisions, la planification de l’approvisionnement et les achats pour permettre la disponibilité continue des produits de Nutrition et de lutte contre le paludisme, de la PF, de la SMI, et du VIH. Le présent guide de l’utilisateur permettra d’utiliser facilement l’outil OSPSANTE. Il fournit des conseils pas à pas pour accéder à l’outil OSPSANTE et générer des rapports.
Rapport de quantification des produits de la planification familiale pour la période de janvier 2016 à décembre 2020
L’un des piliers de la sécurité des produits de planification familiale (PF) est la disponibilité continue et optimale des produits de PF. Une bonne quantification de ces produits fondée sur des évidences est un maillon essentiel dans le cadre de la sécurité des produits, car elle assure la planification et la mobilisation des ressources nécessaires, fournit des données et informations pour l’achat et la distribution efficace des produits. Une bonne quantification peut également réduire les coûts et le gaspillage, surtout dans un contexte de ressources limitées. Un exercice de quantification pour les produits de la PF a été mené avec l’assistance technique et financière de l’USAID/SIAPS et la participation de tous les principaux intervenants, dans le but de produire des besoins prévisionnels et un plan d’approvisionnement pour la période de 2017 à 2020. Les résultats de cet exercice de quantification seront utilisés dans la planification pour mobiliser et obtenir des ressources financières pour la période de quantification. La prévision des besoins a été estimée pour l’ensemble du pays (secteur public et marketing social) pour chacune des méthodes. Le plan d’approvisionnement a été élaboré pour les deux secteurs.
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 overall objective is to provide support and overarching guidance on reproductive, maternal, newborn, child, and adolescent health commodity financing and supply chain management approaches to the Global Financing Facility secretariat and participating countries. Highlights this quarter included an orientation workshop for 10 new GFF countries held in Accra, Ghana, at the end of January 2018, during which there was a parallel session on management of commodities and a technical webinar on commodity management for teams from the 16 existing countries. Technical support was provided for the review of documents, and technical discussions were held in Senegal, Liberia, Guatemala, and DRC. Also during this quarter, SIAPS planned for the transfer of funds from USAID to the E2A project to allow the consultancy to continue beyond the end of SIAPS.
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.
In November 2016, SIAPS offered technical assistance to DPMED to optimize the current medicine registration system, potentially by using the […]
- Therapeutics Information and Pharmacovigilance Centre's Analysis of Spontaneous Adverse Events due to Antiretroviral and Other Medicines
The use of antiretrovirals (ARVs) in combination for treating patients with HIV has greatly ameliorated morbidity and mortality by reducing […]
SIAPS worked with global and in-country partners to improve access to and use of life-saving medicines for women and children, […]