Ten Year Enhanced System

The Drug Supply Chain Security Act (DSCSA), otherwise known as track and trace, is a series of regulatory changes impacting manufacturers, buyers, and sellers of prescription drug in the US marketplace. The overarching goal of DSCSA is to provide greater control and visibility throughout the drug supply chain, from original manufacturer to consumer. The purpose of this regulation is multi-fold, and includes better response to product recalls and prevention and detection of illegitimate (counterfeit) prescription drugs. There are two paramount components to this 10 year plan: exchange of product information between owners and product serialization.

What’s already happened?

T3 Documentation Exchange with each change in Ownership

rxtrail-dscsa-t3-track-trace-document

As you are probably aware, the Drug Supply Chain Security Act (DSCSA) came into full force in 2016, with requirements for Manufacturers, Wholesalers and Dispensers. If you buy, sell, loan, manufacturer, or dispense prescription drugs in the US, you are subject to specific record-keeping requirements now under DSCSA. These new requirements focused primarily on the exchange of “drug pedigree” documentation.
This “paperwork”, known as T3 documentation, consists of 3 components: Transaction History, Transaction Information and Transaction Statement. For a full description of what these components consist of visit rxtrail.org T3 info. The documentation must be retained for no less than 6 years and you must be able to retrieve the documentation, down to the Lot-level upon inquiry by government officials.

What’s happening in 2017?

Product Serialization

By November of 2017, pharma manufacturers are required to serialize saleable units of their products. Serialization in the context of DSCSA means, to assign a uniquely identifying number to the product you are selling. This serialization process includes in many cases a reconstruction of manufacturing production lines, software interfaces, databases and product labeling. These changes are major overhauls in many cases. Manufacturers must now encode MORE information into the barcodes they are producing and store more data. The information that is now required is a unique serial number identifier number (SNI), NDC, Lot Number, Lot Expiration. The standard format of these new barcodes is known as Data Matrix format. Many are familiar already with NDC, Lot Number and Lot Expiration. The US has for quite some time, required manufacturers to encode their product barcodes with the 10-digit FDA National Drug Code (NDC). Some manufacturers, such as vaccine manufacturers, have taken the process further and started to include Lot and Lot Expiration information in the product barcoding. But this SNI thing, it is new.
So take the example of ten vials of Drug A in the near future world of US serialization.
All 10 vials of Drug A may very well contain the same NDC number, Lot Number and Expiration. However, serialization would mean that each of the 10 vials would contain a UNIQUE serial number identifier or SNI.

 SNI = 0001   SNI = 0002   SNI = 0003   SNI = 0004   SNI = 0005
vial vial vial vial vial
  SNI = 0006   SNI = 0007   SNI = 0008   SNI = 0009   SNI = 0010
 vial vial vial vial vial

This requirement poses significant challenges. First of all it should be obvious that this process creates a tremendous amount of data. These serial numbers are intended to aid in retrieving product information which can be challenging given the amount of data being created.

How serialization might impact hospital and pharmacy processes

Barcode scanning technology is used in many different ways throughout the healthcare industry. Specifically for pharmacies and hospitals, barcode scanning technology is useful when:

  • Handling product inventory – checking it in to a med carousel as an example.
  • Repackaging products into unit dose form.
  • Checking product as it is filled – retail pharmacy scanning, robotics.
  • Verifying product at the bedside before it is administered to a patient.

Inventory management, product verification and electronic health record software are built to interpret the data sent by a barcode scanner. This involves reading part or all of the barcode for storage in the system, retrieval of data, confirmation of data, or all of the above.

The key thing with SNI is that the information changes. The barcodes will literally contain MORE and DIFFERENT information. At the package level, manufacturers will use GS1 2D Data Matrix barcode as the machine readable product identifier.

Guidelines were drafted by GS1 US in 2014 to meet DSCSA requirements. Fortunately, many parts of the world have already undergone this serialization process. GS1 recommends the use of industry standard Application Identifiers or AI’s. Application identifiers are numerical codes between 2 and 4 numeric digits that partition (split/demarcate) the barcode data into parts. The AI’s specific to pharmaceutical supply chain are listed below.

– (01) GTIN (Global Trade Item Number) – 14 digit GTIN which contains the encoded 10 digit NDC.
– (21) Serial Number Identifier (SNI) – variable length – up to 20 characters
– (10) Batch/Lot Number – Lot Number – variable length – up to 20 characters
– (17) Expiration Date – Expiration Date – fixed length – 6 digits – YYMMDD

AI’s are further illustrated below in this image adapted from the GS1 US 2014 DSCSA Guidelines.

gs1table

 

Re-programming your barcode scanners

Vendor software updates to barcode-dependent systems to keep pace with all of these changes may be required. One way, that does not necessarily rely on the software vendors, is to deploy data formatting rules to the devices (scanners) you are using to scan medications. This methodology is very popular and has been used by many industries, including healthcare to improve barcode recognition rates and to standardize inventory tracking.
Essentially, what is done here is that the scanners themselves are “loaded with rules”. The manufacturer of your scanning device can usually assist you with this configuration. Typically these manufacturers will provide scanner configuration toolkits that allow you add these custom rules.

As an example, you may want to create a set of rules that reads individual segments of the new data matrix barcodes. The first rule might be Are you a data matrix barcode? The second rule might be Do you contain known AI’s (application identifiers) for Lot, Expiration, and SNI? The third rule might be If the answer to both of those questions is yes, start reading at barcode character 1, and read until you reach AI (17) and send that to the screen. Just like that, you have retrieved an NDC/UPC number (the GTIN segment of the barcode).

For inventory management systems these changes could be positive. If the data is properly utilized, processes such as checking outdates should be a quicker process. Additionally, listing short-dated products on gray market exchanges or when selling between dispensers, should be easier. Reverse distributors, though not currently subject to track and trace regulations, could utilize the data to assist customers in maximizing return opportunities.
It has yet to be determined, whether manufacturers will elect to continue using non-data matrix barcodes, such as linear 1D barcodes used to print UPC numbers. Depending on these production line changes, some of your processes may need to be modified. As an example, if your electronic health record bedside scanning system expects UPC barcode formats, it may very well have problems interpreting the new barcodes that contain the added information. Again, proper barcode scanner configuration rules should help with this.

Beginning in 2018, repackaging companies become subject to the same requirements for serialization. Wholesale distributors follow in 2019 and dispensers (hospitals and pharmacies) in 2020. Each of these business entities will have unique challenges in meeting the DSCSA requirements for serialization. If you have questions regarding this information or your own state of compliance with DSCSA, please contact support@rxtrail.org, or visit RxTrail.org/contact-us/

This article included a brief summary of the changes planned for November of 2017, how they will impact pharmaceutical manufacturers, and how they will possibly impact you as a hospital or pharmacy. This information does not represent legal advice and is provided without warranty.