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.
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
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
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 … Read more
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.
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 … Read more
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 … Read more
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 … Read more
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 … Read more
Inside this issue: Pharmacovigilance in Swaziland Update on 2016-2017 Spontaneous Reporting Systems Medicine Safety Alerts How to Report an ADE