Drug Company Improves The Pedigree Of Its Regulatory Compliance

Date Added: Jan 2010
Format: HTML

One of the United States' largest cancer treatment and research networks was facing a regulatory compliance deadline, which required them to provide pedigree papers for the drugs they distribute. This law, called the Florida Pedigree Law, seeks to provide protection to the prescription drug supply in Florida from counterfeit, diverted, adulterated or contraband substances. The situation being tough given the complexity of the regulations, the short timeframe for compliance and the high cost of non-compliance, this drug company sought help from Deloitte Consulting LLP. It wanted Deloitte to implement an electronic pedigree data management solution within their oncology drug distribution system. This data management solution, called ePedigree, would secure the supply chain of pharmaceuticals distributed to their network of affiliated practices, thus ensuring that the company would be able to adhere to the regulatory compliance. ePedigree, as a data management solutions happens to be more efficient, faster and more accurate than manual record keeping. At the time, Deloitte Consulting practitioners were already assisting the client with another project. Understanding the criticality of the whole situation, they helped the company understand the implications of the regulations and also assisted in developing an approach that would address their needs. A blend of regulatory knowledge, experience with the Oracle systems that would integrate with the ePedigree system and an understanding of warehousing and shipping operations allowed Deloitte Consulting to provide the company with a solution that ensured that every drug distributed through its nationwide network is protected with an ePedigree track and trace system