Standards

Serialization

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Overview

Serialization is not a new concept in the pharma space, but many attempts and implementations have failed to cover the necessary range of users and use cases needed to make them ubiquitous.

The DoseID serial number was primarily designed with unit-doses in mind. But it also accommodates a wide range of objects that interact with, or are related to, those unit-dose medication. For example, the following can also be assigned a DoseID serial number (and have a corresponding RFID tag):

  • A user who interacts with a drug (user badges)
  • A kit, tray, or inventory system used to stock, transport, or dispense a drug (kits, automation devices)
  • A salable-unit case or carton containing multiple unti-dose drugs (parent-child relationships)

The DoseID serial number also has a number of features designed to make it extensible over time and allow for an ecosystem of registrants to operate independently.

Supporting the Widest Range of Use Cases

Pharmacies manage a wide range items in their inventory, but some of these items don’t have NDCs or FDA labeler codes.

Our serial number and EPC schema supports all of the pharmacies’ use cases.

  • Pharma & 503B products with an NDC
  • Supplies with an HRN
  • Any product with a UPC
  • Automation IDs (robots, carousel, cabinets, etc.)
  • Doses compounded in-house
  • Related objects (trays, bins, carts, locations, people, etc.)

Serial Number and EPC FAQs

  • The DoseID Serial Number (and EPC) is a 96-bit number.
  • EPC+TID pairs must be registered. Since the TID on the tag is immutable, it can be used for integrity checks when future lookups of the item occur, helping to prevent errors and detect suspect and illegitimate products.
  • The use of user/extended memory for encoding drug information directly on the tag is prohibited. This has fallen out of favor in other industries that rely on RFID, as its now widely recognized to be limiting and less trustworthy.
  • Once encoded with a serial number, tags must be locked with a non-obvious, non-trivial password. Encoders should rotate their passwords at least every 6 months.
  • Including a DoseID QR Code on the packaging allows for non-RFID systems to quickly parse the serial number, EPC, and URL of an object.
  • Using the EPC as a pointer, API endpoints allow DoseID systems to lookup and store information related to each item.
  • Whenever possible, print the Serial Number (or the last 4 hex characters of the serial number). This is important for troubleshooting and for easy identification of a particular item.
  • In the case that there is no room on the human readable packaging, the serial number can be omitted (determined on a cases by case basis).

Rocuronium Example

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In this example, you can see a refrigerated item that generates a beyond use date ("BUD") upon removal from the refrigerator. Because the item is serialized, and both the refrigerator and ADC are integrated with the Centralized Registry, the ADC can be aware of both the manufacturer's expiration date and the BUD.