ePedigree Track and Trace Solutions for Pharmaceutical Manufacturing Supply Chains

ePedigree Track and Trace? What is it?

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 an electronic pedigree or e-Pedigree) is an electronic document meeting the requirements of the above definition for 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.

View these 2 links for additional information regarding ePedigree from EPCglobal:

An Overview of the Electronic Product Code (EPC)
Documents on ePedigree Standards

View Wikipedia for addition information and resources on ePedigree.

ePedigree Track and Trace Standards for Counterfeit Drug Prevention

The Center for Medicine in the Public Interest estimates that counterfeit drug sales will reach $75 Billion by the end of 2011. 

The Would Health Organization (WHO) has reported that counterfeit drugs may comprise of up to 1% of total sales in developed countries and anywhere from 10-70% in developing countries.  WHO also reports that over 50% of all medicines purchased online from facilities that conceal their physical address have been found to be counterfeit. 

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 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. 

Information from the California Board of Pharmacy on ePedigree regulations
Florida Legislation on ePedigree regulations within the Pharmaceutical Supply Chain

Why use RFID for ePedigree Track and Trace Systems

A variety of technologies can be used to implement ePedigree track and trace systems. RFID and 2D bar codes both are capable of encoding EPC and Serialized Global Trade Item Number (SGTIN) data. As stated above, EPCglobal is currently focusing on creating a global standard for RFID ePedigree and pharmaceutical tracking. Why RFID when other technologies such as 2D bar codes is fully capable of recording the required ePedigree information?

One of the reasons for choosing RFID over bar codes is the multi-scan ability. With bar codes, a line of sight between the scanner and the label is required, with RFID line of sight is not required, and labels (RFID tags) can be read if they are within the range of the reader under defined conditions. RFID technology can avoid inference (in the pharmaceutical supply chain inference is opening a case to see what is inside). This alone will save tremendous time and costs. Currently there are pending ePedigree regulations in the United States which will not allow inference and require non-line of sight technology.

RFID is also capable of storing more comprehensive ePedigree information that a 2D bar code is, such as more descriptive product information, dosage and strength information, and manufacture and expiration dates.  RFID will also record ePedigree transition information such as purchases, invoice data, transfer data, authorization data, and more.  RFID technology for ePedigree track and trace systems and Pharmaceutical tracking will improve visibility and allow companies within a pharmaceutical supply chain to make cost-efficient decisions quickly.

New technology and evolving ePedigree regulations lead companies with in the pharmaceutical supply chain to stay abreast of the latest industry developments surrounding the use of ePedigree track and trace systems. ePedigree Track and Trace Systems with both bar code and RFID Technology provide the ability to trace the chain of custody throughout the pharmaceutical supply chain, meet compliance needs, increase visibility, and improve efficiency.

Consumer safety is vitally important within pharmaceutical supply chain. From raw ingredients to processing, from the wholesaler to the pharmacy, ePedigree track and trace systems provide visibility and support a company's validation of their procedures and protocols. 

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 beyond distribution to the physicians, consumer, 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 with in 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 a 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.

See additional documentation below which includes information on ePedigree systems within the pharmaceutical supply chain.