By: Ilisa Bernstein, Pharm.D., J.D.
The U.S. prescription drug supply is among the safest in the world, but it can be challenging to keep it that way. Criminals – both here and abroad – constantly threaten to replace safe, effective, and high-quality prescription medications with counterfeit, stolen, and otherwise substandard products.
Roughly 4 billion prescriptions were filled at U.S. retail pharmacies last year. That’s a lot of prescription drugs moving through the U.S. supply chain that patients are relying on. In today’s global pharmaceutical environment, in which a large percentage of FDA-approved prescription drug products are made outside of the United States, we are continuously looking for ways to keep the drug supply secure.
Substandard and falsified drugs are global problems that need global solutions and global collaboration. We cannot solve these challenges alone and we at FDA are continually looking for ways to collaborate and learn from our regulatory counterparts around the world.
I’m pleased to share an important new advancement to help protect the U.S. and global supply chain for prescription drugs and other medical products. Over the past four years, FDA led a team of international partners to create the Supply Chain Security Toolkit for Medical Products. Our collaborators included regulators from the 21-nation Asia-Pacific Economic Cooperation (APEC), non-APEC countries, industry stakeholders, representatives from non-governmental organizations, international organizations, and academia.
The goal of this collaboration was to develop strategies to better secure the medical product supply chain across APEC economies and around the world. We also aimed to enhance APEC members’ regulatory standards to secure national and global supply chains, and develop tools that regulators and industry can use for training and for implementing best practices.
The Toolkit is a comprehensive resource that covers the entire supply chain and lifecycle of medical products – from raw materials to patient use. It focuses on developing and implementing processes and procedures designed to enhance global medical product quality and supply chain security.
The Toolkit website provides detailed information and resources related to track and trace, internet sales, detection technology, and much more. The toolkit can be used by industry stakeholders and regulators from around the globe to adopt best practices and to strengthen laws and regulations to protect consumers from unsafe and substandard drug products. It also is a valuable training tool for regulators grappling with the complexities of keeping the supply chain safe.
Training will be coordinated by the United States Pharmacopeia and the University of Tennessee Health Sciences Center, which are APEC Centers of Excellence.
The tools will help regulators worldwide to PREVENT, DETECT, and RESPOND to medical products that threaten the health and safety of patients.
We all will benefit from this hard work. Together with our global partners, we will continue to combat supply chain problems as they arise and increase confidence in the legitimacy of the life-saving prescription drugs that patients rely on.
Ilisa Bernstein, Pharm.D., J.D., is Deputy Director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research