Ensuring Supply Chain Integrity and Security
How secure is your Supply Chain?
Maintaining supply chain integrity and security is critical for ensuring the quality and safety of pharmaceutical products. The pharmaceutical supply chain is complex and involves multiple stakeholders, including suppliers, manufacturers, distributors, and healthcare providers. Managing supply chain risks and ensuring the integrity and security of pharmaceutical products throughout the supply chain is essential for protecting patient safety and maintaining regulatory compliance.
The U.S. FDA says the U.S. drug supply chain remains one of the safest in the world. However, the drug supply chain has become increasingly complex as it reaches beyond U.S. borders. Threats to the supply chain such as counterfeiting, diversion, cargo theft, and importation of unapproved or otherwise substandard drugs, could result in unsafe, ineffective drugs in U.S. distribution.
During the Pandemic, the Director of National Intelligence issued a 2020 report Supply Chain Risk Management that included that key U.S. supply chains had been identified as one of the five pillars of the National Counterintelligence Strategy of the United States 2020-2022.
Three Focus Areas to Reduce Threats to Key U.S. Supply Chains:
- Enhance Capabilities to Detect and Respond to Supply Chain Threats
- Advance Supply Chain Integrity and Security across the Federal Government
- Expand Outreach on Supply Chain Threats, Risk Management, and Best Practices
U.S. supply chain integrity and security concerns resulted in an Executive Order on America’s Supply Chain which was implemented on February 24, 2021. The Administration set forth policies to strengthen the resilience of America’s supply chains. The Secretary of Health and Human Services, in consultation with the heads of appropriate agencies, [was required to] submit a report identifying risks in the supply chain for pharmaceuticals and active pharmaceutical ingredients and policy recommendations to address these risks.
On May 23, 2022, the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) released the nation’s first Essential Medicines Supply Chain and Manufacturing Resilience Assessment report by the U.S. government. Unsurprisingly, this report identified supply chain challenges and constraints and offered prioritized strategies and implementation actions to increase supply chain resilience for the essential medicine supply chain, identifying four broad areas:
- Increased supply chain coordination, security, and transparency
- Expanded onshore or nearshore production capacity
- Advanced manufacturing capabilities and innovative research and development
- Purchasing, stockpiling, and distribution approaches
Supply Chain Integrity and Security (SCIS) is defined as a set of policies, procedures, and technologies used to provide visibility and traceability of products within the supply chain. This is done to minimize the end-user’s exposure to adulterated, economically motivated adulteration, counterfeit, falsified, or misbranded products or materials, or those which have been stolen or diverted.
SCIS involves reducing risks that arise anywhere along the supply chain, from sourcing materials and products to their manufacture and distribution. The goal is to detect adulterated, falsified, or counterfeit products and prevent them from entering the sup