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SIAPS’ Technical Assistance to Strengthen Medicines Regulation in Namibia 2011-2017

SIAPS helped improve pharmaceutical product quality by building the capacity of the Namibia Medicines Regulatory Council (NMRC) to review medicine registration dossiers; inspect pharmaceutical manufacturing facilities and finished (imported) products at ports of entry and in the marketplace; to chemically test medicines compliance with established standards; and monitor overall compliance with applicable regulatory standards and norms. In addition, SIAPS supported MOHSS in strengthening the management and regulation of medical devices and support equipment in Namibia, and in revising the National Medicines Policy, a crucial of pharmaceutical regulation and governance. SIAPS supported the reconfiguration of the desk-top Pharmadex tool to a web-based application. In general, the six-year support of the SIAPS project to the NMRC contributed to the strengthening of this regulatory agency, which in turn, contributed to improvements in service delivery to the clients. The registration process improved, to decrease the long-standing backlog of dossiers; PMS ensured safety and quality of pharmaceuticals; and implementation of web-based Pharmadex provided a means for clients/applicants to upload applications and follow up the progress of dossier review, which reduced workload for NMRC staff. SIAPS provided continuous TA for the restructuring of the NMRC.

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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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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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Toward Building Resilient Pharmaceutical Systems: SIAPS Final Report

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.

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Implementing a Dashboard for Pharmaceutical Information in Namibia

SIAPS supported the MoHSS to design and implement a web-based electronic information system (dashboard) for both patient and stock status in Namibia. It was designed to improve coordination among facility, district, regional, and national stakeholders involved in HIV commodity management; increase the use of pharmaceutical information for management decision making at all levels of health care; and improve planning for financial resources for pharmaceutical commodities. The dashboard comprises a module for monitoring 22 pharmaceutical services delivery indicators, a module that summarizes the number of people accessing ART services, and an early warning system against stock-outs of antiretrovirals (ARVs) and other essential medicines.

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Building a resilient pharmaceutical system: SIAPS event highlights program’s work in Namibia

The SIAPS Program wrapped up its years of work in Namibia with an event in Windhoek on March 14. The program has worked in the country since 2011 to strengthen pharmaceutical management, helping to improve access to quality-assured medicines and related skilled services. SIAPS’ activities focused on enhancing pharmaceutical service delivery, health workforce availability, information […]

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Sustaining SIAPS’ impact: What’s next for pharmaceutical systems strengthening?

By Francis Aboagye-Nyame, SIAPS program director Greatjoy Mazibuko was a pharmacist at the Oshakati Intermediate Hospital in Namibia working with ART patients. Every day, he rose at dawn, not knowing how many patients he would have that day. He often worked for 12 hours or more; patients were kept waiting for hours, perhaps having traveled […]

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Adopting the Pharmacovigilance Monitoring System for the Philippines National Tuberculosis Program

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.

 

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Process of implementing e-TB Manager, 2008-2016: a summary of 10 countries

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.

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Model Business Process Flows for Registration of Medicines: A Guide for Establishing a Standardized Generic Version of SIAPS Pharmadex Software

The introduction of Pharmadex has so far targeted individual country requirements. Currently, under the African Medicines Regulatory Harmonization initiatives, efforts are underway to adopt common and harmonized processes and communication platforms for medicine registration in regional economic communities, such as EAC, ECOWAS, and the Southern African Development Community. The purpose of this report is therefore to describe the currently known processes in selected countries and develop a model set of business processes for medicine registration based on internationally accepted standards. These model business processes can then serve as the basis for establishing a model version of Pharmadex’s registration module.

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