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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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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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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.

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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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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.

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Benin National Supply Chain Assessment

In an effort to improve the health status of the Beninese population, a priority activity included in the 2015 convention between the US Government, represented by USAID, and the Benin Government, represented by the Ministry of Health (MOH), was to conduct a comprehensive assessment of the public health supply chain, focused on essential medicines that are associated with the package of low-cost, high-impact interventions. SIAPS undertook this assessment in close collaboration with and under the leadership of the MOH, represented by the National Health Products Supply Chain. This report presents information on the capability, maturity, and operational performance of Benin’s health supply system, along with a strategic plan of interventions to address identified weaknesses that will allow reliable supply and use of medicines in the health system.

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Department of Health Training Guide on Warehousing and Distribution of Family Planning, TB, and other Health Commodities in the Philippines

This guide is written for the DOH Philippines’ LMD. It can be used as support material in the training and development of new and existing staff involved in warehouse and distribution operations at all levels, particularly those who are involved in the process of receiving, putaway and storing, picking and packing, and dispatching of FP, TB, and other health commodities in DOH warehouses.

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Development of Standard Operating Procedures to Strengthen Demand and Supply Planning of DOH Philippines

In line with the objective of the Department of Health (DOH) to strengthen supply chain management for pharmaceuticals and health commodities and ensure access for all Filipinos, this technical assistance aimed to support the DOH in strengthening demand and supply planning for pharmaceuticals. The assistance aimed to facilitate consensus building to harmonize demand and supply planning activities of the DOH, initiate the development of selected SOPs on demand and supply planning at the central level, identify data sets and requirements for performing consumption-based quantification for selected commodities.

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Leadership, Management, and Governance Evidence Compendium: Medical Products, Vaccines, and Technologies

This brief on “Medical Products, Vaccines, and Technologies” is one of the chapters of the Leadership, Management, and Governance Evidence Compendium. The USAID-funded Leadership, Management, and Governance (LMG) Project collaborated with the USAID-funded SIAPS program to develop this chapter. The compendium contributes to the evidence base and advocates for continued investment in Leadership, Management, and Governance (L+M+G) activities by examining and documenting the evidence that exists regarding L+M+G’s role in strengthening health system performance in low and middle-income countries. The compendium’s five chapters draw on existing evidence documented in peer-reviewed and grey literature to describe the mechanisms that illustrates L+M+G’s role in the health system and the mechanisms through which L+M+G influences health system functioning.

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