Combating Substandard & Counterfeit Medicines

Over the past few decades, the supply chain for pharmaceuticals and their ingredients has expanded around the world, and so has the presence of substandard and counterfeit products. Notable adverse events related to poor quality medicines (e.g., heparin and glycerin contamination) have brought increased attention from policymakers, regulators, manufacturers, and consumers to the threat of using poor quality medicines.

To combat substandard and counterfeit medicines, PQM supports the development of monographs for medicines needed to treat USAID priority diseases, collects and disseminates evidence-based data through collaborative research, and makes available necessary technical resources. These tactics are carried out by an expert staff that includes internationally trained doctors, scientists, chemists, and Good Manufacturing Practices (GMP) specialists with access to state-of-the-art laboratories and technology focused on providing needed technical assistance at local, regional, national, and international levels. PQM staff actively participate in multimedia conferences and workshops to stimulate dialogue on poor quality medicines and the dangers they pose to patients and stakeholders everywhere.

Monograph Development

To strengthen the quality control (QC) of essential medicines in USAID priority health programs, PQM works with USP staff to facilitate the development of new testing methods and monographs. With USP implementing the PQM program, pharmacopeial monographs and reference standards can be developed for new medicines and formulations if needed. PQM

Collaborative Research

Results collected from research and monitoring activities provide evidence-based data on quality trends on essential medicines in the marketplace. PQM undertakes quality research—independently and collaboratively with major health organizations—providing the quality assurance (QA) component to research on malaria resistance, prevalence of substandard and counterfeit medicines, and other topics of importance. PQM

Technical Resources

Integral to the objectives that guide PQM is the concept of building sustainable systems. PQM helps countries build capacity in medicine quality and provides technical expertise to national and international health organizations. PQM develops regional capacity by establishing regional centers of excellence in QA, strengthening regional networks among national laboratories, and developing web-based communications. PQM adapts its programs to meet the needs of the nation. PQM