TB patients on second-line treatment experience a significant number of adverse effects. Some TB medicines result in adverse effects that, if not continuously monitored, can become serious and/or permanent and may hinder patient adherence to treatment. A number of other risk factors can also impact the safety of patients taking TB medicines, including drug interactions […]
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SIAPS, in partnership with the FDA, NTP, and LCP-NCPR, conducted a readiness assessment to determine the current information technology (IT) infrastructure, human resources, processes, and data management and quality control mechanisms available and to identify gaps in the current PV recording and reporting of patients in the seven Programmatic Management of Drug-Resistant TB (PMDT) treatment facilities implementing the 9MTR for multidrug-resistant (MDR)-TB study. The results of this assessment will provide inputs for developing the PViMS implementation plan.
An online system for monitoring and reporting cases of adverse drug reactions and lack of efficacy of medicines comprehensively addresses the need for improved access to quality, safe, and effective medicines. “The evaluation and analysis of PAIS system in Ukraine has brought out gaps and identified recommendations on operational PAIS system optimization and enhancing its […]
New Approaches and Tools Help Protect Patient Safety, Increase Access to Quality Medicines in Ethiopia
The SIAPS team has helped the Ethiopian Food, Medicine, and Health Care Administration and Control Authority (FMHACA) and many health facilities in the country incorporate product quality reporting into its national adverse drug event (ADE) reporting system. This has proven to be an efficient and cost-effective measure to detect products with problems in quality and […]
Strengthening Pharmacovigilance Systems in Swaziland to Improve Patient Safety and Treatment Outcomes
SIAPS mobilized stakeholders from the Swaziland National AIDS Program (SNAP) and the National Tuberculosis Control Program (NTCP) to introduce and implement the Sentinel Site-based Active Surveillance System for Antiretroviral and Anti-TB (SSASSA) treatment programs. SIAPS partnered with the Pharmacovigilance Unit of the MOH to create the protocol and tools for the electronic SSASSA system, and developed a patient recruitment system at HIV and TB sites.
By publishing this newsletter, The Directorate General of Drug Administration (DGDA) will be able to communicate information on the safety of medicines and other health products to health care professionals, consumers, and the public on a regular basis. In the event of an emergency, when serious risks arise, that information will become crucial to ensuring the availability of safe, effective, and quality medicines.
Structured Pharmaceutical Support Visits Help Maintain High Standards of Antiretroviral Treatment in Namibia
Structured technical support supervisory visits (SSVs) have helped pharmacists in Namibian public sector health facilities maintain high standards in managing the supply and dispensing of antiretrovirals (ARVs) and other essential medicines. “SSVs keep us on our toes. They help us ensure that we adhere to the set standards, and we also learn from the various […]
Technical Highlight: Strengthening Bangladesh’s National Pharmacovigilance System: Lessons Learned and Opportunities
In 2012, the US Agency for International Development-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program, implemented by Management Sciences for Health, started working with the DGDA and conducted a comprehensive assessment of the DGDA’s regulatory systems and capacity. As part of the recommendations made in the assessment, SIAPS provided technical support to the DGDA to revive the national PV program and establish an Adverse Drug Reaction Monitoring (ADRM) cell. This cell, which is responsible for collecting adverse event reports from health care facilities, hospitals, and pharmaceutical companies, maintains and analyzes adverse event databases, including data entry and quality assurance, and shares adverse event information with WHO’s International Drug Monitoring Center (WHO-UMC) at Uppsala.
In April 2015, the US Agency for International Development (USAID) and Janssen Therapeutics officially launched the bedaquiline donation initiative. As part of this initiative, Janssen committed to providing bedaquiline at no cost to 30,000 patients with multidrug-resistant tuberculosis (MDR-TB) over a four-year period. Bedaquiline is the first anti-TB medicine to be approved by the U.S. Food […]
The SIAPS May 2016 Storify includes web content on SIAPS technical leadership in pharmacovigilance across multiple online platforms. Check out the selection of website features, tweets, and other posts below. [View the story “SIAPS Focus on Pharmacovigilance: May 2016” on Storify]