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, … Read more

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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 … Read more

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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 … Read more

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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 … Read more

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PSS Insight: A Tool for Measuring Progressive Pharmaceutical Systems Strengthening

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 … Read more

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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 … Read more

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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 … Read more

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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) … Read more

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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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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 … Read more

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