E-Pedigree and Serialization

According to the 2006 Compliance Policy Guide for the Prescription Drug Marketing Act of the U.S. Food and Drug Administration (FDA), “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”. A pedigree is simply a standard record that traces the route of products like drugs from the point of manufacture to the end user. E-pedigree then, is the electronic version of the pedigree requisite. E-pedigree is synonymous with epedigree and electronic pedigree, and its primary objective is to shield consumers from counterfeit drugs or contaminated medicines.

The Pedigree Standard was ratified as a universally accepted standard by EPC Global on January 5, 2007. It has also delineated an XML explanation about the product history as it passes through the highly complex supply chain. XML or Extended Markup Language, is a detailed set of rules specified for electronically encoding documents.

Subsequent to this, the year 2008 saw most of the states enact a law requiring some form of a pedigree regulation, with many opting for epedigree as well. However, the current epedigree requirements are limited to pharmaceutical companies having to submit complete reports as spreadsheets, text files or in PDF formats with information on the lot number, potency of the drug, its date of expiry and so on.

An original epedigree requirement includes
the following:

• The lot number
• Potency of the drug
• Date of expiry
• Manufacturer
• Specifying the National Drug Code and the Electronic Product Code
• Details about the distributor, the wholesaler or the pharmacy
• Unique identifying code of the unit on sale.

The principal requirements of an E-Pedigree system according to the California Business and Professions Code section 4034(a) state, that a Pedigree “means a record, in electronic form containing information regarding each transaction resulting in a change of ownership of a given dangerous drug, from sale by a manufacturer, through acquisition and sale by one or more wholesalers, manufacturers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering or dispensing the dangerous drugs. The pedigree shall be created and maintained in an interoperable electronic system, ensuring compatibility throughout all stages of distribution.”

A few concepts need clarification to be understood as part of the pedigree requirements:

• Interoperability - This has been added to the 2006 legislation, since it is believed that industry inputs would help in making the pedigree concept function more effectively. The complex supply chain is comprised of numerous parties at various levels, and they should not have to buy new hardware or software to be able to access the pedigree information provided by the manufacturer in some highly specific format he may opt for his electronic pedigree. The sole purpose of this requirement was to ensure that manufacturers and companies do not evolve their own distinct proprietary systems for electronic pedigrees, in order to prevent proliferation in the system as well as make the reading process of pedigrees more complicated by entities further down in the supply chain, namely wholesalers and pharmacies. Subsequently, a pedigree messaging standard was ratified by EPCglobal in January 2007. This was a purely document based standard. A second EPCglobal EPCIS standard is close to getting finalized, and will permit creation of a pedigree or appending one, along with a data storage management system.
• Serialization at the unit level becomes important for the recognition and identification of container boxes used to store prescription drugs in pharmacies or at wholesale outlets, and also check the container’s pedigree. For as long as the original container is kept, the entire history of its ownership will be available for scrutiny. Hence, “the pedigree shall track each dangerous drug at the smallest package or immediate container distributed by the manufacturer, received and distributed by the wholesaler, and received by the pharmacy or another person furnishing, administering or dispensing the dangerous drug”.

• Repackaging: On the basis of a single pedigree, the repackaging must allow tracing the drug to the original manufacturer. Therefore, “ a single pedigree shall include every change of ownership of a given dangerous drug from its initial manufacturer through to its final transactions to a pharmacy or other person for furnishing, administering or dispensing the drug, regardless of repackaging or assignment of another National Drug Code (NDC) Directory number”.
• Return: Any return of a dangerous drug must be traceable on the basis of a single pedigree. ”Any return of a dangerous drug to a wholesaler or manufacturer shall be documented on the same pedigree as the transaction that resulted in the receipt of the drug by the party returning it.”

All products move down the long supply chain, and it is imperative for the company to carry all the previous epedigree information ahead. This will ensure that the entire lineage of every unit is available at the final point of sale.

The epedigree laws are in a stateof confusion due to the constantly changing deadlines and “drop dead” dates set for complying with the tracking and authentication procedures. The new deadlines are years ahead of the original ones set by FL and CA. Serialization is an essential requirement. Regulation cannot be a business driver for companies that are likely to focus only on achieving compliance levels. Companies that are able to track and serialize saleable packages in unit levels like a bottle of 20 pills instead of a case or pallets are able to enhance their business value in the following manner:

• Accurate adjudication will help to minimize cost of chargebacks, which typically cost a pharmaceutical manufacturer 2-15% of gross revenue.
• Increased accuracy in Medicare or Medicaid pricing calculations will help to minimize risks. This becomes easier by having complete knowledge of fees, rebates and the chargebacks that have to be applied to a single unit sale. Improper calculations of Medicare and Medicaid pricing have led to the imposition of fines to the tune of over $4 billion.
• Limited liability to recall an entire lot of a product due to theft of a non-serialized shipment.
• Higher manufacturer visibility in the field of specialization like the wholesale distribution network would help to make accurate forecasts about demand and sales and about marketing programs initiated.

Initiating a simple epedigree system is crucial and significant as a first step, but a more standardized and automated approach would yield higher levels of public safety. While suggestions have been made about an Automated Epedigree System, it is not yet a prerequisite in any state. This can be attributed to the fact that this system can operate only if substantial changes are initiated in the data interchange taking place between supply chain companies. They would also necessitate advanced track and trace technology like bar codes or RFID. California is one state, which almost meets the Automated Epedigree System requirements. The California Board of Pharmacy (CBOP) published a set of “E-Pedigree Requirements” in March 2008, and expects to see these implemented in a phased manner between 2015-2017. Any rules formulated by the FDA for the regulation of electronic pedigree, would supersede the ones published by California, which have been prepared as an XML standard document as opposed to the system requirement of an “interoperable electronic system”.