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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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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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Keep Maternal, Newborn, and Child Health Medicines Safe: Introducing MNCH commodities into a pharmacovigilance system

As countries aim to achieve the Sustainable Development Goals, there is an emphasis on increasing the availability of medicines. However, poor quality products or dispensing methods may decrease treatment effectiveness or even result in patient death. ADEs negatively affect patient care and increase costs to the system. A functioning PV system monitors these events and triggers actions to minimize their impact. While some disease-specific areas, such as tuberculosis, have made PV a regular tenant of their treatment programs, medicines used for maternal, newborn, and child health (MNCH) are often ignored in reporting. This case study highlights steps taken to ensure the safe use of medicines for mothers, newborns, and children through regular adverse drug event (ADE) reporting as part of the national pharmacovigilance (PV) program in Bangladesh.

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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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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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Assessment of DPM Medicine Regulatory System, Mali

A comprehensive assessment of DPM’s medicine regulatory system was conducted September to October 2017 by SIAPS funded by USAID. The WHO Global Benchmarking Tool was used for data collection. The scope of the assessment was focused on the five regulatory functions: national regulatory systems, medicines registration and marketing authorization (MA), pharmacovigilance (PV), market surveillance and control, and clinical trial oversight (CTO).

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National Guideline on the Pharmacovigilance System in Bangladesh

The objective of the National Guideline on the Pharmacovigilance System in Bangladesh is to guide health care providers (HCPs) and other key actors in the health and pharmaceutical sectors on the operations of the PV system. This document gives an overview of what PV is, how to detect and classify ADRs, and the structural organization of the system in Bangladesh. It also describes the reporting system to the NPC and expected outcomes. The document aims to help expand the roles and responsibilities of stakeholders in the country’s PV system to identify, analyze, and minimize the risks associated with pharmaceutical products. It also promotes better and broader use of PV data for patient safety.

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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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Philippines Pharmacovigilance Training

SIAPS conducted a training on pharmacovigilance (PV) to increase the capacity of the National Tuberculosis Program, the Lung Center of the Philippines, Pharmaceutical Division, and Food and Drug Administration. Strengthening the capacity of staff in these organizations and other stakeholders in this area of PV reinforces current safe scale-up efforts and introduction of these lifesaving regimens. Furthermore, providing training for staff in data management, causality assessment, and signal detection enhances expansion of safety monitoring to other medicines used within the health system in the Philippines.

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