In the realm of pharmaceuticals, trust is paramount. Patients rely on medications to improve their health, manage chronic conditions, and enhance their quality of life. But what happens when counterfeit drugs infiltrate the supply chain, threatening patient safety and eroding that trust? The recent surge in counterfeit Ozempic (semaglutide) injections in the United States has raised serious concerns.  

Ozempic, a powerful medication from Novo Nordisk used to treat type 2 diabetes, has been a game-changer for patients. Intended initially to manage diabetes, semaglutide has garnered massive popularity for its ability to promote quick weight loss in patients. Novo Nordisk also offers a semaglutide drug, Wegovy, for weight loss.  

Unfortunately, counterfeit versions have infiltrated the drug supply chain globally, putting lives at risk. FDA is actively investigating counterfeit Ozempic. Thousands of units of the product have been seized, but the battle is far from over. The needles from these samples are also counterfeit, compromising sterility and increasing the risk of infection for patients. Ozempic counterfeits have also been found in Europe. The Austrian federal health office warned that the counterfeits contain insulin rather than semaglutide, the active ingredient in Ozempic. 

The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 to enhance drug traceability and protect patients. However, the recent Ozempic counterfeiting incident highlights its limitations: 

• Serialização: The DSCSA mandates serialization (unique identifiers) for drug packages. Yet, counterfeiters find ways to mimic these identifiers, slipping through the cracks. 
• Verification Challenges: The European Medicines Verification System (EMVS) has been successful in Europe, but the U.S. lacks a similar nationwide system. Verification at the pharmacy level remains critical. 

We can collectively address the counterfeit medicinal drugs issue by having:

Strengthened Serialization

• Augment with Product Authentication Technologies: In addition to serialization, provide an additional layer of protection through non-replicable covert and overt technologies for unique identification at the item level. 

Change Management 

• Program: Recognize that anti-counterfeiting and anti-diversion requires a programmatic approach, not just technology deployment. This approach requires aligning the strategy, technology, organization, training, and resources for success.  
• Forensics: Utilize extensive data to investigate and address supply chain threats

Collaborative Efforts

• Industry Collaboration: Pharmaceutical companies, distributors, and regulators must collaborate. Sharing data on suspicious products and counterfeit trends can bolster detection.  Collaborating with companies fighting counterfeits in other sectors and leveraging their learnings can also be beneficial. 
• Global Cooperation: Counterfeit drugs transcend borders. International cooperation is essential to tackle this issue effectively. 

Public Awareness

• Educate Patients: Empower patients to recognize signs of counterfeits. Encourage them to verify products before use. 
• Reporting Mechanisms: Establish user-friendly channels for reporting suspected counterfeit drugs. The FDA’s MedWatch program is a valuable resource. 

The battle against counterfeit Ozempic demands collective action. Let us fortify our defenses and embrace innovation to safeguard patients. Doing so can restore trust in the drug supply chain, ensure that every Ozempic injection is genuine and improve patient health.  

Outlining the role and information of each stratum in preventing drug counterfeiting is necessary. Patients need to be proactive in recognizing and reporting any difference in their medicines and healthcare professionals need to educate patients about the differences between genuine and counterfeit drugs. Ultimately, supply chain transparency is crucial to prevent the addition of counterfeit drugs in the supply chain. Finally, there is a need for policymakers and international organizations to set up relevant national and international guidelines and ensure compliance to curb the rising cases of drug falsification. 

 How Systech can help address drug counterfeiting 

Systech offers comprehensive solutions to help manufacturers and distributors combat drug counterfeiting effectively, building on the foundation of regulatory compliance and going well beyond.  

• Serialização: Systech’s serialization solutions enable brands to assign unique identifiers to each product. This approach allows for real-time tracking and monitoring, making it challenging for diverted products to go unnoticed.  
• Track and Trace: With Systech’s industry-leading track and trace capabilities, manufacturers can monitor the movement of their products throughout the supply chain. This monitoring helps identify and address diversion and unauthorized distribution.  
• Digital Product Authentication: Systech provides a non-replicable, non-additive, covert digital product authentication solution that works with existing 1D and 2D barcodes and packaging to deliver immediate counterfeit detection. With an easy-to-use smartphone app, brands and their trading partners can instantly verify product authenticity—anywhere in the supply chain.  

 Systech’s anti-counterfeiting solutions are vital in safeguarding the medicinal drugs supply chain. Implementing these advanced tools ensures product quality and patient safety while minimizing revenue loss. In an industry where authenticity and quality are paramount, Systech is a powerful ally in the fight against diversion.  

Authenticity saves lives. Vigilance protects the future. Together, we prevail.