Pharmaceutical Packaging and ePedigree Requirements

By the time a patient picks up a prescription from a pharmacist, the drug has likely passed through the hands of nine other entities in the pharmaceutical supply chain. The US Food and Drug Administration intends to automate and enhance the safety of the pharmaceutical supply chain by establishing electronic pedigrees (ePedigrees) for drug products. An ePedigree is an electronic log of all parties at all points in the supply chain that possessed a given drug. The goal is to track drug products at the unit level as they are manufactured, packaged, sold, returned, and recalled.

To help ensure the accuracy of the system, the pharmaceutical industry is considering two machine-readable automatic identification methods-barcodes and radio-frequency identification (RFID) tags-to store ePedigree data. Regardless of which technology is selected, packagers and label designers will need to plan for the day when a manufacturer or distributor is required to add ePedigree information to the unit-level package.

Some firms prefer barcodes because they are familiar with the technology, and because barcodes are inexpensive to print and apply. A two-dimensional barcode stores more data than do other formats, but reading barcodes is sometimes a labor-intensive process. A barcode must be applied at a position where it is visible and can be easily scanned. A variable-data printer could be used, either on an in-house printing line or at a contract partner’s facility, to generate barcodes with data that are unique to each individual dose, compared with preprinting the same barcode on every package for a particular product. Especially with variable printing, the packaging line should include a vision system to confirm the barcode’s readability at the time of printing.

Other firms prefer passive RFID tags, which cost more than barcodes but do not need to be visible to be read. This characteristic reduces the amount of handling. RFID readers can also write data to a tag, thus data can be added or changed at any point in the production line. In addition, RFID tags can store more data than a barcode and can include digital signatures to prevent the data from being read, modified, or copied by unauthorized personnel. A summary of public comments submitted to FDA in 2008 shows that RFID is the preferred technology (1). Passive RFID tags, which vary in size, shape, and style, can be embedded into a cap, wrapped around a vial, or printed on a label. Liquids and metal can influence the movement of radio waves, so RFID tag placement would have to be tested during the package-design process to ensure maximum read rates when items are packaged at the case or pallet level.

Part of a packager’s inspection and verification process should include barcode scanners or RFID readers linked to a middleware solution, which applies filtering, formatting, or logic to the data captured by a reader, thus enabling software applications to process them. Packagers should confirm the content of the recorded data, look for duplicate codes, and capture the ePedigree information in their own databases to meet possible regulatory requirements and assist with recalls.

The pharmaceutical industry must answer the following questions before it can select and implement an ePedigree solution:

• As a drug product moves through the supply chain, will the ePedigree information generated at each ownership transfer be stored in a central database or in the RFID tag on the product itself?

• Who would own, manage, maintain, and protect the data in a centralized database of ePedigrees? How would participants in the supply chain access this information securely? What would happen if the database becomes inaccessible?

• If the ePedigree information is stored on the RFID tag, what security will be implemented to protect it from unauthorized readers?

• Should anyone be allowed to access and use ePedigree information for purposes such as marketing? Should a manufacturer or packager be able to monitor how its drug is distributed? How is consumer privacy affected by ePedigree systems?

• What scanning equipment or network access will be required at each point in the supply chain, including pharmacies, hospitals, and clinics?  How will this affect the shipping, receiving, and distribution processes?

• How will the costs to establish a system to record and read ePedigree data be shared among members of the pharmaceutical supply chain?

Patients may still be years away from knowing what other entities handled their prescriptions as well as they know their pharmacists. The California ePedigree plan is expected to become the model for FDA’s national efforts to identify, validate, authenticate, track, and trace prescription drugs, but the California State Board of Pharmacy delayed its deadline to track dangerous drugs electronically within the state. The new plan is for a staggered implementation from 2015 to 2017.

Reference
1. FDA, “Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication,” Fed. Regist.73 (55), 14991–14992 (Mar. 20, 2008). http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2008-N-0121, last accessed Apr. 30, 2009.

Louis M. Parks, is chief executive officer of SecureRF Corporation, 175 Post Road West, Westport, CT 06880, tel. 203.227.3151, ext 1301, LParks@SecureRF.com.