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Training Workshop on Quantification with Quantimed and PipeLine Tools in Freetown, Sierra Leone

The purpose, objectives, and activities of this program are designed to reflect the Government of Sierra Leone’s Health Sector Recovery Plan. Specifically, SIAPS will provide support for strengthening the supply chain system, including capacity-building activities that focus on district-and peripheral-unit levels to assist in restarting programs of the Ministry of Health and Sanitation (MOHS); the DDMS (which is responsible for coordinating and providing pharmaceutical services, including promoting rational use of medicines); the National Pharmaceutical Procurement Unit; and the Pharmacy Board of Sierra Leone.

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Optimizing the Marketing Authorization Process in Benin: Institutionalization and Development of Medicine Registration Standard Operating Procedures

DPMED is responsible for registration of medicines prior to importation by licensed importers and their use by health providers and consumers. However, the department is hindered in execution of its mandate because of several challenges. The extent of illegal and unregistered medicines in circulation is not uncommon. DPMED is constrained by its capacity to effectively regulate the pharmaceutical sector with consequent inefficiencies in key processes, such as medicine registration, leading to delayed access to life-saving medicines. For these reasons, the Benin MOH sought assistance from USAID to help strengthen the medicine registration system for effective performance to hasten access to quality assured medicines. The SIAPS Program conducted a rapid assessment of the medicine registration system in November 2016, and in August 2017, conducted a detailed assessment of the medicine registration system at DPMED. Based on the findings from the two assessments conducted by the SIAPS Program, several recommendations were made. One of the recommendations was to optimize the medicine registration process by establishing a consistent way of handling registration dossiers to promote an efficient process. Standard operating procedures (SOPs) were developed so that the registration department could operate more efficiently. In addition, the SOPs served as a prerequisite for establishing an effective and sustainable electronic medicine registration system.

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Restructuring the Directorate for Drugs and Medical Supplies

The Directorate for Drugs and Medical Supplies (DDMS) plays a key role in providing technical guidance and setting strategic direction in policy formulation, service delivery, standards, laws and regulations, and objectives for the pharmaceutical sector in Sierra Leone. It is also involved in stakeholders’ collaborations and coalition building, resource mobilization and deployment of resources, and monitoring and oversight. SIAPS identified DDMS as the MOHS entity well placed to be capacitated to implement and sustain the interventions SIAPS put in place. It is therefore necessary to review and finalize the DDMS structure at all levels to reflect this expanded role, especially with regard to the ongoing decentralization process, the capacity that must be developed, and aligning DDMS’ work plan with SIAPS. As part of its technical assistance to DDMS, SIAPS supported revision of the treatment registers and the report, request, and issue voucher. SIAPS also provided technical assistance in the training of trainers and national cascade training for introducing the newly developed treatment register.

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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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Standard Procedure for Inspection of Retail and Wholesale Pharmacy (Post-Marketing Surveillance)

The purpose of this SOP is to provide guidance to DGDA officials on the steps required to conduct PMS of medicinal products available in retail and wholesale pharmacies, drug shops, and outlets. It is applicable to medicinal products, including traditional complementary and alternative medicines (TCAM), vaccines, and biological products.

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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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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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