DSCSA 2024: Ten Count: Number 5- Counterfeit Drug Threats in the US Supply Chain
Ten Count Consulting reflects on 2024 with our list of top DSCSA moments and stories from 2024.
Number 5:
Why Full Implementation Is Critical Amid Rising Counterfeit Drug Threats
The full implementation of DSCSA has been and will continue to be one of the most challenging and monumental endeavors the industry has undertaken. To persevere in the arduous task, we must not lose sight of why it matters. The alarming continuation of counterfeit drugs into the U.S. market highlights a harsh reality that the events that led to the creation of the Drug Supply Chain Security Act (DSCSA) in 2013 are still a threat. Recent reports of the rise in fake medications, especially weight loss drugs like Ozempic and Wegovy, posing escalating risks to public health and safety. This crisis emphasizes the urgent need for the DSCSA to become fully operational to help bring greater security to the pharmaceutical supply chain and protect consumers.
CBP's Growing Battle Against Counterfeit Drugs
U.S. Customs and Border Protection (CBP) is on the front lines of this fight. In a recent operation, CBP officers in Cincinnati intercepted nearly $270,000 in unapproved FDA drugs, including counterfeit Ozempic, Wegovy, Trulicity injections, Botox, Minoxidil, and Riaxon. These shipments, originating from multiple countries, targeted vulnerable U.S. consumers searching for cheaper medications online. CBP warned, "These counterfeit drugs are dangerous and often manufactured in unregulated facilities, which can lead to serious health risks for consumers." Read more here.
Online Purchases Fueling the Counterfeit Crisis
The convenience and affordability of online shopping have made consumers easy targets for counterfeit drug traffickers. Some counterfeit weight loss medications have been discovered to contain toxic substances like antifreeze. Salvatore Ingrassia, Port Director for CBP at New York's JFK Airport, cautions, "Buying medications from unverified online sources is extremely risky. You simply don’t know what you’re getting or who you’re buying it from." Learn more in this CBS News article.
Why the DSCSA Must Be Fully Implemented Now
The DSCSA was designed to prevent, quickly detect, and respond to counterfeit, stolen, or contaminated drugs that enter the U.S. pharmaceutical supply chain. However, the surge in counterfeit drugs proves that the vulnerabilities the DSCSA seeks to address still exist. Full and expeditious implementation of the DSCSA is critical to protect consumers and maintain the integrity of the pharmaceutical supply chain.
Steps Consumers Should Take
To mitigate risks from counterfeit medications, consumers should:
- Purchase from Verified Sources: Always buy prescription drugs from licensed and reputable pharmacies.
- Consult Healthcare Providers: Seek professional guidance before purchasing medications, especially online.
- Be Wary of Bargain Prices: Deep discounts on prescription drugs can indicate counterfeit products.
- Utilize tools available: Always contact the product complaints number listed on the product or manufacturer website immediately if you have reason to believe a product is dangerous. In addition, utilizing DSCSA outlined product verification and tools such as this webpage created by Elli Lilly allow patients the ability to upload the 2D barcode and check if the medicine’s serial number is consistent with medicines manufactured by Lilly and obtained in the United States and The National Association of Boards of Pharmacy's Safe Site Search Tool which allows users to verify if a website selling medications has been vetted.
Conclusion
The ongoing surge in counterfeit drugs reveals that the pharmaceutical supply chain remains vulnerable. The type of counterfeit events that led to the DSCSA's enactment are still risks the industry needs to continue working to stop. Full implementation of the DSCSA is not optional, it is essential. The health and safety of millions of Americans depend on it.
The List Revealed So Far:
Number 9: FDA 483s Issued for DSCSA Requirements
Number 8: Two-Year Exemption for Small Dispensers
Number 7: DSCSA Stabilization Period Checkpoint PDG-FDA Joint Public Meeting
Number 6: DSCSA Exception Handling: Building Resilient Processes for 2025 and Beyond
Stay tuned to our blog over the coming days as we share the remaining 4 highlights of 2024
Number 4
Number 3
Number 2
Number 1
