Counterfeit medications can be a real threat to patient safety. It is estimated the counterfeit drugs have increased year over year to provide approximately $200 billion in revenue annually to illegal operators and have caused approximately 1,000,000 deaths each year. In one incident, international authorities seized 25,000,000 counterfeit medicines in just one week. Almost every pharmaceutical manufacturer and its associated supply chain partners have been affected by counterfeited and diverted medicines. In response to these global incidents, the government agencies have implemented serialization and track and trace requirements to protect patients.

Anti-counterfeiting and diversion events impact the physical end-to-end pharmaceutical supply chain from the packaging site to the final patient. Pharmaceutical, parenteral and biologic products subject to external venerability throughout their transportation between packaging, distribution or customer sites. To combat counterfeiting and diversion, countries and their government agencies are adopting complex track and trace serialization models to protect patients.