ePedigree Adoption

Introduction

A pedigree is a paper or electronic document (e-pedigree) that enables a single view of the product and order and is used for drug authentication. The pedigree goes with the drug and tracks the change of custody as the drug passes through the supply chain.

The growing movement towards utilizing electronic pedigrees "ePedigrees" to track drugs in the pharmaceutical supply chain has become critical. By this date, wholesale distributions of all prescription drugs in the State of Florida must be accompanied by a complete chain of custody record. Companies found to be receiving or sending drug shipments without pedigrees may open themselves up to fines, orders to discontinue operations or event criminal investigation.

Similar pedigree requirements are expected to follow in California, Indiana, Nevada and several other states. The FDA is also considering steps to require drug pedigrees at the national level. Most companies affected by pedigree regulations will not have the option to take a wait and see approach. Now is the time to begin implementing a pedigree strategy and considering your need for a trusted solution partner.

The long-term requirements is unknown, but using Florida as an example allows us to map out what the future will probably look like.

In Florida, pedigree solutions must perform the following:

• Authentication of each owner of a drug product from current owner back to the original manufacturer shipment
• Validation that data on the pedigree matches the physical product received
• Association of pedigree information to outbound shipments
• Confirmation that shipped products have complete and accurate pedigrees

Companies will turn to solutions that are economical. Unfortunatly, these solutions need to be designed and implemented to meet each companies environment.

Some of the challenges:

Technology:
Usability of how that epedigree is created, moved, and tracked.
Is the software easy to use?

Data Storage:
ePedigrees will require a large amount of data storage shared between partners.
Is there back-up?

Authentication:
Each partner in the supply chain must authenticate the chain of custody back to the manufacturer, and maintain a record of this authentication.

Regulatory changes:
How will the laws affect your state?
Will there be a federal requirement?
What about other states?

These changes to the law will require software updates to meet compliance from state to state.

Infrastructure:
To secure the data, share and authenticate requires a large redundant computing infrastructure. ePedigree data must be stored for extended periods of time and ensure high availability if requested by a trading partner or government investigator. Please see how we meet these criterias with our RNS Services.

ePedigree Solutions will help early adopters establish long-term relationships, manage costs and federal requirements. Addressing these issues upfront and early will help us create a strategy that addresses these issues.

To see how the RxServer2 can meet your needs please feel free to contact us below.

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