To combat the burden of substandard, falsified and unauthorized medical products, USP, particularly through the PQM+ Program assists countries in Africa, Asia, Eastern Europe, Latin America and the Caribbean, to develop post-marketing surveillance (PMS) programs.
The PQM+ predecessor PQM program, had developed guidance for the implementation of risk-based PMS to help countries optimize the use of their financial and human resources, and ensure the sustainability of PMS programs. To further support the implementation of risk-based approaches during PMS activities, PQM+ developed the online Medicines Risk-based Surveillance (MedRS) tool. This tool automates into a single platform the science and practice of developing sampling protocols for post-marketing quality surveillance utilizing a risk-based approach. The tool applies risk management principles to evaluate multiple factors in several dimensions of risk to facilitate selection of medicine, geographic location as well as the facility/outlet within the supply chain for sample collection. The tool assists countries identify the most susceptible medicines to be collected, prioritize sampling to the most vulnerable locations and determine the number of samples required for a statistically significant assessment.
New users are required to register before access to this tool can be granted. Training on ‘how to use this tool’ is recommended and can be arranged upon request.
Click below to view a “Demo Version” of the tool or to “Access the MedRS” tool.
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To assist countries combat the burden of falsified and substandard medicines, the PQM Program assists countries in Africa, Asia, Eastern Europe, Latin America, and the Caribbean to develop sustainable Post-marketing Surveillance (PMS) programs.
PQM has developed the Medicines Risk-based Surveillance (MedRS) Tool to assist countries effectively implement risk-based post-marketing surveillance. The MedRS tool automates the science and practice of risk-based post-marketing surveillance into a single platform. The tool evaluates three dimensions of risk—medicines, geographic location, and supply chain—to assist countries identify the most susceptible medicines, determine the number of samples required, and prioritize sampling to the most vulnerable locations. Detailed PMS methodology is described in the user manual of the accompanying PMS tool.
Since 1992, USP has been funded by USAID to support developing countries address public health threats related to medicines quality. The Promoting the Quality of Medicines (PQM) program[pon1] provides technical assistance to build capacity of medicines regulatory authorities, and quality assurance/control systems in countries with emergent health systems. Furthermore PQM helps countries combat substandard and falsified medicines, and ensure access to critical medicines by providing technical assistance to improve GMP compliance of manufacturers committed to producing quality-assured priority medicines for malaria, HIV/AIDS, tuberculosis, neglected tropical diseases, and maternal and child health. For more information