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Functional Comparison of Electronic Medicines Registration Systems

In November 2016, SIAPS offered technical assistance to DPMED to optimize the current medicine registration system, potentially by using the web-based medicine registration tool Pharmadex. After the assessment at DPMED in August 2017, SIAPS found that the SIGIP-ARP system in place was a software recommended for the regional West African Economic and Monetary Union (WAEMU) member states and was preferred by DPMED. Hence, it was jointly resolved to strengthen the system already in place. A server room was setup and a rack server installed to hold the current and any other future systems for DPMED (e.g., inspection software). SIGIP-ARP was modified to improve its performance, which has enabled DPMED to do concurrent data entry of registration applications. DPMED is currently progressing on this task, and SIGIP-ARP can generate monitoring reports, which the director can use for management purposes. DPMED has yet to develop monitoring and evaluation indicators to track the data entry.

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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 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).

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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.

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Storage Improvement of Peripheral Health Units in Four Districts in Sierra Leone

Proper storage conditions and inventory control have a positive effect on medicine quality, data/recording quality, transparency, and the prevention of loss and expiries that lead to wastage. Medicines can lose their potency over time, and the substances that remain as they break down can be harmful. Poor and disorganized storage can lead to deterioration and result in stock-outs, overstocking, and expiries as personnel will not know what medicines are available. The purpose of the improvement is to prevent early degrading of medicines and improve reporting and stock management practices to create visibility and transparency. It will also help in making timely decisions in cases of stock-out or overstocking.

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SIAPS West Africa Regional Project End of Project Report

Project dates: 2013-2017

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SIAPS Guinea End of Project Report

Project dates: 2012-2017

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Strengthening Medicine Registration in Benin: A Detailed Assessment

In November 2016, at the request of USAID/Benin, SIAPS conducted a rapid assessment of the medicines registration system of the Direction de la Pharmacie, du Médicament et des Explorations Diagnostiques (DPMED) in Benin and made recommendations to address the challenges arising from its current information system. The assessment identified opportunities to improve regulatory processes for the efficient and transparent registration of medicines. The purpose of SIAPS’s technical assistance visit in August 2017 was to conduct a situational analysis regarding the findings and recommendations made after SIAPS conducted a rapid assessment in November 2016. The goal was also to develop appropriate recommendations and a plan for the implementation of Pharmadex software and the management system of the medicines registration process at DPMED, Benin.

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OSPSANTE: Guide de l’Utilisateur

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.

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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.

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Continuous Results Monitoring and Support System

This is the report of the first continuous results monitoring and support system (CRMS) exercise in Bombali District, which was conducted in May 2016. The purpose of the report is to highlight the findings and observations of the CRMS exercise. A total of 104 health facilities (HFs) (one hospital, 18 community health centers (CHCs), 57 community health posts (CHPs), 26 maternal and child health posts (MCHPs), and two clinics) were assessed using a comprehensive checklist based on selected service and system indicators. The CRMS exercise examined different indicators that focused on stock availability; consumption; expiry; number of patients treated; availability and performance of pharmaceutical information tools; storage conditions; staffing; training; and supervision.

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