Tag Archives | governance

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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SOP for the Adverse Drug Reaction Advisory Committee (ADRAC) on Adverse Drug Event Reporting

The purpose of this SOP is to describe the procedures and activities of ADRAC in the review and evaluation of ADE reports received by ADRMC. It is applicable to all ADE reports received for medicinal products, including Unani, Ayurvedic, herbal, homeopathic and biochemical systems of drugs, vaccines, and biological products.

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SOP for the Adverse Drug Reaction Monitoring Cell in DGDA on Adverse Drug Event Reporting

The purpose of this SOP is to outline the management of spontaneous reporting of ADEs by the ADRMC. It is applicable to medicinal products, including Unani, Ayurvedic, herbal, homeopathic, and biochemical systems of drugs, vaccines, and biological products. The SOP has been written to describe the procedures to be used by ADRMC members to collect, record, review, and manage ADE reports received by the PV center.

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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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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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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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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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