Pharmaceutical e-Pedigree Track and Trace Software
Over 40 countries are today working on track and trace laws and regulations to help secure pharmaceutical products supply around the world. Either already in place, pending for enacting or in development, these mandates will have differing scopes, codification formats, and requirements for event reporting and information exchange, resulting in a wide variety of factors to consider and scenarios to manage. Take a look to our global serialization landscape for pharmaceutical products to have an overview of the state of the different laws and regulations pertaining to drug serialization and aggregation around the world as well as the main milestones. The Drug Supply Chain Security Act (DSCSA), like most serialization mandates, includes many changes and some of them are highly complex in nature. Change equates to risk. The greater the change and the complexity of it the higher the level of risk. Serialization also helps protect a brand from product diversion or counterfeits and creates a unique link with consumers or patients. Ideally a serialization suite should be robust, versatile and quickly deployable unit identification and traceability software suite enabling to globally track & trace an unlimited number of products, anytime, anywhere.
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.” 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.
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 authenticity of products. ePedigree Track and Trace Solutions provide benefits such as standardization compliance, protection as ePedigree track and trace systems will help authenticate pharmaceutical products from manufacturing beyond distribution to the physicians, consumer, and retail dispensers.
ePedigree Track and Trace Solutions also Improve Efficiency and Reduce Costs as they 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.
ePedigree Track and Trace Solutions also Improved Inventory and Returns Processing by 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. With the changing ePedigree track and trace landscape the benefits are likely to increase.
ePedigree Systems should be interoperable and needs to be compatible with other solutions within the pharmaceutical supply chain.
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.
With a goal of protecting consumers from contaminated, counterfeit, and expired drugs, the Federal Drug Administration (FDA) will require companies distributing prescription drugs to become ePedigree compliant.