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Prescription Status Track
Project HIE STANDARD
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. A Pedigree or ePedigree is a system that was set in place to meet the requirements of the Prescription Drug Marketing Act of 1987 (PDMA). The Act was signed into law by President Ronald Reagan on April 22, 1988. The PDMA and subsequent federal regulations establish specific requirements in several vital areas: Distribution, Storage, Disposal, Record-keeping, Security and Violations. Civil and criminal penalties were also established for individuals and corporations found guilty of noncompliance with the law. On multiple occasions, the Food and Drug Administration has been successful at procuring counterfeit drugs over the Internet. The World Health Organization has stated that 10% of drugs sold around the globe are also counterfeit. Both state and federal governments were looking for a way to help safeguard the medicines that many people rely on.
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. Under the pedigree requirement, each person who is engaged in the wholesale distribution of a prescription drug in interstate commerce, who is not the manufacturer or an authorized distributor of record for that drug, must provide to the person who receives the drug a pedigree for that drug. The PDMA states that an authorized distributor of record is a wholesaler that has an "ongoing relationship" with a manufacturer to distribute that manufacturer’s drug. However, the PDMA does not define "ongoing relationship."
Recomendations for Track and Trace Technology
Active Intervention Architecture™
FDA stated, in the 2006 Task Force Report, that although significant progress has been made to set the stage for widespread use of e-pedigree, this goal, unfortunately, will not be met by 2007. FDA is optimistic that the considerable momentum and interest in widespread implementation of e-pedigree will continue and remains committed to working with stakeholders to expeditiously make this happen.
The 2006 Task Force Report also states that FDA continues to believe that RFID is the most promising technology for implementing electronic track and trace in the prescription drug supply chain and that stakeholders should move quickly to implement this technology. FDA recognizes that implementing an RFID-enabled drug supply chain is challenging and urges manufacturers to take a risk-based approach to implementation by first tagging the products that are most vulnerable to counterfeiting and diversion, based on factors such as the sales price, volume sold, demand, ease of counterfeiting, and prior history of counterfeiting or diversion, among other things. Stakeholders urged FDA not to mandate RFID in order to give the private sector time to continue with developing standards and build the appropriate and necessary infrastructure. We listened to their concerns and did not require RFID use at this time.
The 2006 Report also considered several technical issues related to adoption of electronic track and trace technology that were perceived as obstacles to implementation and are in need of resolution. These include:
Mass serialization and unique identification of each drug package;
Universal pedigree with national uniform information; and
Privacy issues and the need for consumer education about RFID and the labeling of RFID-tagged drug products in order to help prevent unauthorized disclosure of personal information.
FDA's vision of a safe and secure prescription drug supply chain is based on transparency and accountability by all persons who handle the prescription drug throughout the supply chain. With the implementation of the pedigree regulations in December 2006, FDA expects that supply chain stakeholders will move quickly to adopt electronic track and trace technology, implementing RFID or an alternative track and trace technology in a phased-in approach. Although there are important issues that still need resolution, these issues should not hinder the forward progress and momentum toward widespread adoption. In the meantime, FDA believes that public health would be better protected if all stakeholders work cooperatively to enable all distributors to pass pedigrees.
FDA will do its part in effectively enforcing the law, in conjunction with other Federal, state, and local entities, to protect Americans from criminals who attempt to undermine the public health by introducing counterfeit and diverted prescription drugs into the U.S. drug supply. At the same time, stakeholders must remain vigilant in their responsibility to provide safe and effective drug products to U.S. patients.
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.
Usability of how that epedigree is created, moved, and tracked.
Is the software easy to use?
ePedigrees will require a large amount of data storage shared between partners.
Is there back-up?
Each partner in the supply chain must authenticate the chain of custody back to the manufacturer, and maintain a record of this authentication.
How will the laws affect your state?
Will there be a federal requirement?
What about other states?
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