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.
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.
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.
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.
In 2012, when the US Agency for International Development (USAID) awarded the SIAPS Program, it tasked the program with developing a measurement framework and corresponding indicators for determining whether investments in pharmaceutical systems strengthening are contributing to the development of stronger, more sustainable pharmaceutical systems. At that time, there were no widely accepted definitions for a pharmaceutical system or pharmaceutical systems strengthening. Furthermore, there was no standardized approach for measuring progress toward stronger, more sustainable pharmaceutical systems. In 2014, SIAPS conducted a series of literature reviews and held a consultative meeting of SIAPS partners and experts in the field to propose definitions for a pharmaceutical system and pharmaceutical systems strengthening. Once these key parameters for measurement were identified, SIAPS arranged them within a framework for measurement to guide the selection of indicators and determine a basis to guide the measurement process. Once the framework was in place, an extensive review process of existing indicator-based assessment tools and manuals was undertaken to develop an indicator bank from which to select measures for the PSS Insight tool. Working with experts from Boston University School of Public Health, SIAPS selected key indicators that form the basis of a tool to measure progress in pharmaceutical systems strengthening, using defined indicator selection criteria. The resulting tool, called PSS Insight, is a web-based data management system comprising 117 indicators intended to measure progress in pharmaceutical systems strengthening, both across countries and over time.
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.
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.
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.
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.
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).