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.
This tool also allows MRAs in LMICs to plan and implement Post-Market and Surveillance activities for vaccines.
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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This tool is made possible by the generous support of the American people through the U.S. Agency for International Development (USAID) Cooperative Agreement No. AID-7200AA19CA00025. The contents are the responsibility of U.S. Pharmacopeial Convention (USP) and do not necessarily reflect the views of USAID or the United States Government.
USP is an independent, scientific nonprofit public health organization and is not a part of the United States Food and Drug Administration (FDA) or any other U.S. government agency. This program, PQM+, is unaffiliated with, and has not been evaluated by FDA. References to FDA or to FDA publications do not constitute FDA endorsement of the PQM+ program or of the information provided by it.
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This Application, The Medicines Risk-based Surveillance Tool Ver.2.0, including the platform, all its features and content (the "MedRS") is a service made available by The United States Pharmacopeial Convention ("USP") and the Promoting the Quality of Medicines Plus (PQM+) Program. The Application, its content, information, and services provided on or through the Application ("Content") may be used solely under the following terms and conditions ("Terms of Use").
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7. DISCLAIMER. THE MEDICINES RISK-BASED SURVEILLANCE TOOL (MedRS), AND THE CONTENT THEREOF IS PROVIDED "AS IS" AND WITH ALL FAULTS. TO THE FULLEST EXTENT PERMITTED BY LAW, USP SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTY OF MERCHANTABILITY OF A COMPUTER PROGRAM, AND THE IMPLIED WARRANTY OF ACCURACY. THERE IS NO WARRANTY THAT THE INFORMATION CONTAINED WITHIN IT WILL FULFILL ANY OF YOUR PARTICULAR PURPOSES OR NEEDS. USP MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT TO THE MEDICINES RISK-BASED SURVEILLANCE TOOL (MEDRS) ACCURACY, COMPLETENESS, OR CURRENCY; AND USP SPECIFICALLY DISCLAIMS ANY OTHER WARRANTY, EXPRESS, IMPLIED, OR STATUTORY, INCLUDING BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. USP SHALL NOT BE LIABLE ON ACCOUNT OF ANY SUCH ERRORS, OMISSIONS, DELAYS, OR LOSSES. YOU AGREE THAT IN NO EVENT WILL USP BE LIABLE FOR THE RESULTS OF YOUR USE OF THE MEDICINES RISK-BASED SURVEILLANCE TOOL (MEDRS), FOR YOUR INABILITY OR FAILURE TO CONDUCT YOUR BUSINESS, OR FOR INDIRECT, SPECIAL, OR CONSEQUENTIAL DAMAGES. THE FOREGOING LIMITATION OF LIABILITY AND EXCLUSION OF CERTAIN DAMAGES SHALL APPLY REGARDLESS OF THE SUCCESS OR EFFECTIVENESS OF OTHER REMEDIES.
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Information Regarding the Promoting the Quality of Medicines Plus Program
The information provided on this website is not official United States Government information and does not represent the views or positions of the United States Agency for International Development (USAID) or the United States Government. For more information about USAID's Privacy and Security Policy, please visit http://www.usaid.gov/privacy-policy.
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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
http://www.usp.org/global-health/promoting-quality-medicines