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Standard Operating Procedures for Planning and Implementing a Continuous Results Monitoring and Support System in Sierra Leone at the Primary Health Unit Level

Since May 2016, the Directorate of Drugs and Medical Supplies (DDMS) and SIAPS have supported district health management teams (DHMTs) to implement the continuous results monitoring and support system (CRMS) in their respective health facilities. By the end of 2017, 10 of the 13 districts and more than 1,000 health facilities had conducted three rounds of quarterly CRMS supervisions, reviewed the evidence in stakeholder review workshops, and produced reports. The indicators tracked are generally classified as service indicators (monitoring treatment uptake, consumption, stock status, and rational use) and system indicators (monitoring availability and functioning of information systems and forms, storage and handling, availability of skilled staff, and capacity building). CRMS supervisors use a checklist and various tools and forms to complete their findings and observations; they also provide real-time mentorship and support to address challenges. The findings and observations of CRMS exercises are summarized and presented to key stakeholders and owners of the system in a CRMS review forum where actionable plans are discussed and operationalized by the next quarterly exercise. The purpose of this standard operating procedure (SOP), which was prepared as a job aid, is to provide a frame of reference for implementing a CRMS to conduct comprehensive, participatory, and responsive monitoring using the first exercise as a baseline to track trends in improvement following continuous engagement of target facilities. This approach is in line with supportive supervision and monitoring system but is more proactive and action oriented.

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Report of a ToT and Cascade Training on Leadership Development Program for Pharmacists from the Public Sector of the Ministry of Health and Sanitation of Sierra Leone

The pharmaceutical sector in Sierra Leone faces several challenges. The Ministry of Health and Sanitation (MOHS), in collaboration with different partners, is in the process of strengthening the capacity of district and peripheral health facilities (hospitals and peripheral health units (PHUs)) to ensure an uninterrupted supply of essential medicines, manage supply chain activities through an improved nationwide pharmaceutical management information system, and promote rational medicine use for better health outcomes. USAID support to the MOHS through SIAPS focuses on pharmaceutical management systems strengthening and supply chain management through capacity building and technical assistance to improve governance, management and leadership, selection and quantification, pharmaceutical management information systems, rational medicine use, and CRMS. The purpose of conducting MSH’s LDP training was to build the capacity of Sierra Leone’s DDMS, district/hospital pharmacists, and SIAPS staff in leadership, management, and governance. The goal was to ensure that the directorate, its district/hospital pharmacists, and SIAPS Sierra Leone staff would be equipped with the knowledge and skills to manage and lead the different components of the program efficiently in a transparent and participatory manner. The purpose of the training of trainers (ToT) for the LDP was to establish a pool of local LDP facilitators who could cascade the program to other DDMS staff and district/hospital pharmacists throughout the 13 districts.

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Using Support Supervisory Visits for Monitoring and Mentorship for Pharmaceutical Services Delivery in Namibia

SIAPS has supported the Division: Pharmaceutical Services to conduct support supervisory visit (SSVs) to monitor and assess progress of the supported programs and provide recommendations to further strengthen implementation of pharmaceutical service delivery. The SSVs are used to monitor the extent of implementation of interventions aimed at strengthening pharmaceutical services in MRMDs, hospitals, and primary health care (PHC) facilities; identify challenges in the services; provide onsite support; and make recommendations to address the challenges. These visits are carried out once a year, and the SSV teams check whether issues identified from previous visits have been addressed. SIAPS has supported the MOHSS to implement strategies to strengthen the inventory management of antiretroviral (ARV) medicines and the ART pharmaceutical system. A stronger inventory management system will enable the country to cope with the scale-up of ART services, which increased quantities of health commodities and more complex inventory management tasks.

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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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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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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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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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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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