What is ePedigree Track and Trace?
The United States Food and Drug Administration (FDA) defines drug pedigree in the 2006 Compliance Policy Guide for the Prescription Drug Marketing Act.
“A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.” (View FDA 2006 Compliancy Policy Guide)
An ePedigree (also referred to as an electronic pedigree or e-Pedigree) is an electronic document meeting the requirements of the above definition for a drug pedigree.
The main goal of an ePedigree is to protect consumers from contaminated medicine and counterfeit drugs. “ePedigree track and trace” is a term in the pharmaceutical manufacturing supply chain used to describe an auditable electronic record to track and trace every step taken by prescription drugs as they move from the manufacturing floor to the final end user. ePedigree Track and Trace Systems will ideally provide an extremely accurate process for pharmaceutical tracking of ePedigree records.
Another organization involved in the ePedigree standards is EPCglobal. EPCglobal is an organization that was set up to achieve global adoption and standardization of Electronic Product Code (EPC) technology. The main focus of EPCglobal currently is to create a global standard for RFID and the internet to share ePedigree data via an EPCglobal network. EPCglobal has proven to be instrumental in global ePedigree track and trace standardization progress.
ePedigree Track and Trace Standards Prevent Counterfeit Drugs
With the growing threat of counterfeit drugs and the growing global regulatory pressure to standardize ePedigree Track and Trace systems, pharmaceutical tracking is a hot topic throughout many pharmaceutical supply chain companies. Many companies are already doing everything they can to secure their pharmaceutical supply chain and ensure the authenticity of products. States in the US such as Florida and California have already begun to address vulnerabilities in the pharmaceutical supply chain and require more comprehensive ePedigree Track and Trace Systems.
Benefits of ePedigree Track and Trace Solutions
- Standardization Compliance – as outlined above there are already many regulations in place in regards to pharmaceutical tracking, and as we progress into the future these ePedigree track and trace regulations will become more standardized and continue to increase in requirements.
- Protection – For the brand and especially for the consumer. ePedigree track and trace systems will help authenticate pharmaceutical products from manufacturing and beyond distribution to physicians, consumers, and retail dispensers.
- Improve Efficiency and Reduce Costs – ePedigree track and trace systems will support and automate internal procedures (receiving, put away, repackaging, kitting, shipping, and returning products), thus improving efficiency and reducing costs within the pharmaceutical supply chain. ePedigree and pharmaceutical tracking will also greatly reduce the costs and negative impacts of a recall.
- Improved Inventory and Returns Processing – ePedigree track and trace systems will improve the accuracy and visibility of inventory information at the manufacturing, warehouse, retail, and institutional levels. Improved inventory control will also decrease the occurrence of returns which are estimated to range from 3-5% of all drugs shipped. ePedigree Track and Trace systems can provide improved inventory control and return reduction resulting in a positive effect on profitability.
These are just a few of the benefits that can be associated with ePedigree track and trace systems and proper implementation. As the ePedigree track and trace landscape continues to change the benefits are likely to increase and expand.
Tips for ePedigree Systems:
Interoperability or “Standards-Based” – The ePedigree track and trace system implemented will not be the only solution available and needs to be compatible with other solutions within the pharmaceutical supply chain.
ePedigree Reporting – A term that covers any and all electronic reporting requirements that each track & trace regulation includes. A good technology partner will monitor global ePedigree track and trace requirements and begin working on its implementation immediately.
RFID and Bar code Data Capture – ePedigree track and trace systems needs to be capable of easily handling serialization data capture of both RFID and bar code technology. Certain jurisdictions mandate one or the other and good ePedigree systems will flex to either technology.