When you start a company, your goal is to create a popular and profitable product. You are decidedly not thinking about the fact that your product will get counterfeited and sent to the gray market when it does get popular...

Do you wish the data across your pharma serialization lines was more accessible?

As someone who has worked in enterprise software for a long time, the “disconnected” nature of  packaging line data is pretty incredible. Using Systech as an example, we may see network connectivity from enterprise systems to Level 3 Guardian, but rarely visibility to Level 2 Advisor and Level 1 Sentri.

Essentially, each line is its own island. We need to change that!

Pharmaceutical serialization has been looked upon as a panacea for the rampant global issue of counterfeiting. Now that enforcement data has become available on the US Drug Supply Chain Security Act (DSCSA) and EU Falsified Medicines Directive (FMD), it’s time analyze the results. Has serialization put an end to counterfeiting?

Spoiler alert. According to the EU IP Office, pharmaceutical counterfeiting has not slowed down, but is a growing threat.

Drug repackagers face unique challenges under the Drug Quality and Security Act (DQSA), driven by their distinctive position in the pharmaceutical supply chain. One major US drug repackager needed a solution with a wide breadth of features and comprehensive configurability to get in compliance with DQSA so they reached out to Systech for assistance.

A few months ago, the government of the Russian Federation adopted Order Number 791-r, which appears to have significance for pharma serialization there. The primary deviation from the pharma serialization specification that has dictated the government pilot in Russia since early 2017 is the addition of two new data elements to the datamatrix barcode on secondary packaging. For the pilot, the datamatrix barcode contained:

Last month, GS1 US published a report on a DSCSA barcode assessment they conducted last year with two of the largest wholesale distributors in the US, AmerisourceBergen and McKesson.  The goal of the assessment was to take a “snapshot” of pharmaceutical manufacturer progress toward meeting the serialization requirement of the Drug Supply Chain Security Act (DSCSA) by analyzing drug packages actually in the market.

Pharmaceutical manufacturers are working non-stop to get the serialization systems in place necessary to meet the USA DSCSA mandate going live this November, and the EU FMD mandate going live the following February of 2019.  If serialization projects aren’t in full flight at this time, there is a significant chance that a manufacturer will not meet the deadline, not be compliant and not be able to distribute product in those geographies.

President of the Russian Federation, Vladimir Putin, signed a new law the last week of December 2017 that is important for pharmaceutical manufacturers distributing products to or manufacturing in Russia.  It establishes January 1, 2020 as 

Last week, Systech participated in the FDA DSCSA Pubic Meeting, held in Silver Spring, MD at FDA headquarters.  The meeting was two days long and was aimed at discussing the possible characteristics of the Enhanced Drug Distribution Security (EDDS) phase under the Drug Supply Chain Security Act (DSCSA) beginning in November of 2023.  The meeting was broken down into four primary topics:

Systech is a member and strong supporter of GS1 Healthcare, the global group that promotes standardization in healthcare product and entity identification.  On October 17, 2017 in Chicago, GS1 Healthcare held their fall Global Healthcare Conference.