Treffer: Drug Supply Chain Security Act of 2013 and It’s Computer System Implementation

Since 1987, the federal government and state governments, have tried to combat counterfeit drugs from entering the United States and the states' pharmaceutical supply chain. The latest attempt to prevent counterfeit drugs from entering the state drug supply chain was the California E-Pedigree drug tracing program that was to be implemented by the end of 2017. The California E-Pedigree system uses GS1 PDMS tracing system as its guideline. Since all of the states use paper format pedigree systems, California would have been the first electronic pedigree system in the U.S. However, on November 27, 2013, the President of the United States signed into law the Drug Quality Security Act (DQSA). Title II of DQSA is called the Drug Supply Chain Security Act (DSCSA) and it removes all existing or future drug track or trace systems including pedigree systems from all states. DSCSA does establish a new federal drug tracing program that uses pedigrees and product identifiers for verification of the drugs being accepted by the buyer. Although the full implementation of the DSCSA will take about ten years from its enactment, the basic structure of the new federal tracing program is laid out. My thesis will analyze the current state of the pharmaceutical industry, the impact of counterfeit medicine, and anti-counterfeit technologies. We will proceed to analyze the DSCSA to create a basic logical model and show a possible implementation of its verification process. Additionally, we will discuss DSCSA model as to its effectiveness of the basic design against the entrance of counterfeit medicine into the United States Pharmaceutical Supply Chain. This will be followed by a conclusion.