Wednesday, January 30, 2019

Is there an inherent risk in DSCSA’s approach to verifications?

A constant battle which has waged since the beginning of serialization regulations in pharma is the notion of “Spirit of the Law” vs “Letter of the Law”.  In the case of DSCSA companies have, undoubtedly, aligned their strategy and implementations on the “Letter of the Law” more-often-than-not.

If the law doesn’t say I have to aggregate- I’m not aggregating. 

If the law doesn’t say I have to randomize serial numbers- I’m using sequential.   

Which brings us to our next “Spirit” vs “Letter” debate- how to support verifications under DSCSA.  Verifications are an intriguing component because while so much focus has been on what has to be done for DSCSA- generating serial numbers, printing barcodes on products, capturing data- verifications are really the industry’s first foray into actually using DSCSA.

Let me start by providing what I think the “Spirit” and “Letter” of verifications are under DSCSA

Members of the pharma supply chain, the FDA and ultimately patients themselves should gain value from the presence of a unique identifier (and other associated data) on their prescription drugs and subsequently should have tools to use that data to request feedback whether, to the greatest degree of certainty feasible, the unique identifier is legitimate or not.   

Of course, even the purest supporters of serialization/traceability must recognize that a unique identifier (and associated data) alone can never be trusted to say with 100% certainty whether a product is legitimate or not.  The only way to truly verify a product is with scientific testing or other evaluation of the product itself (Thanks John Keogh).

But in the “Spirit” of verifications under DSCSA the industry should strive to put in place processes and systems that use all information available to them to provide the most accurate verification responses possible.  Verifications are, after all, at the heart of why DSCSA even exists.  If we are not making every effort to ensure verifications provide value (e.g. accurate responses) then in fact DSCSA may actually hinder product security by forcing a unique identifier onto items that can be easily exploited by counterfeiters.

Under DSCSA, the term “`verification' or `verify' means determining whether the product identifier affixed to, or imprinted upon, a package or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the repackager, as applicable in accordance with section 582.”

In the simplest terms, DSCSA requires that when presented with a product identifier (GTIN, SN, Lot, Expiry) someone or some system must provide a response whether those data values match with the values assigned to a product that is, to the best of their knowledge, still a valid product.   Any burden of proof as to how the verification response was determined is entirely on the industry and individual vendors to define.

For most companies the required product identifier verification will be done by their serialization systems.  Thus, in functional terms, serialization systems have some procedure that can take in a product identifier, do some checks, and spit out a response.  

At that point every company will have to decide for themselves whether the product identifier check, the only one required by DSCSA, is the only check that will be performed.    

History says most pharma companies will take that approach and proof of that is already apparent with the rapid adoption of VRS.  VRS was built to support the needs of large wholesalers who have to deal with the highest volumes of saleable returns, which now under DSCSA must be verified before they can be sold again. VRS itself is a great accomplishment, building a standards-based approach which facilitates the routing and communication of verification requests and responses- all done in a matter of seconds. However, that alone tells me all I need to know- the industry is rallying around the “Letter of the Law”- do the product identifier verification, provide a response quickly and move on.

But even when inclined to follow the “Letter of the Law” companies must surely recognize that the product identifier verification, which will often be the only check done, has a tremendous amount of importance and responsibility placed on it, right?    And serialization vendors, recognizing the same criticality and importance, must be investing significant R&D and leveraging advanced algorithms and technologies like AI to ensure the most accurate verification responses are provided, right?   (Do you sense my sarcasm?)

Here’s where things get intriguing- take a poll of the 5 major serialization system vendors and ask them how, systematically, they verify a product identifier?  You’re likely to get 5 different answers.

That alone is cause for concern-but again doesn’t mean any one vendor is more-or-less compliant under DSCSA.  More intriguing is to dig deeper and question how robust are these ‘checks’ being done by the serialization systems to determine if a product identifier is verified or not?

Unfortunately, serialization vendors have never been a model of transparency when it comes to demonstrating how their platforms work, but nonetheless, I welcome all vendors to state their position on how they perform verifications. (and actually show it working).  I hope I get some replies!!

Given my experience with serialization implementations here is what I would *hope* is a feasible set of checks which serialization systems use to verify a product identifier.   To be clear, I am a “Spirit of the Law” guy so I don’t consider the checks below to necessarily be adequate, I simply think this is a feasible set given the maturity of serialization implementations/systems I’ve seen to date.  At the same time, I also know some serialization systems are not capable of these checks.
  • Unique identifier (SGTIN) must be commissioned and associated to the corresponding lot and expiry
  • Unique identifier must not have reached an ‘end-of-life’ (e.g. decommission, destroyed, etc.)
  • Unique identifier must not be associated to a lot or itself directly marked in any status which should prevent further distribution (e.g. quarantine, recall, suspect)
  • If verification request is from a trading partner, unique identifier must have been shipped and associated to a DSCSA transaction

I was fortunate to gain experience with a solution provider who had in-depth serialization and authentication solutions in use by companies outside of pharma who leveraged the tools for brand protection purposes.  What I can say with the utmost confidence is if those companies were presented a solution that used the criteria noted above, they would swiftly dismiss it- identifying it as an inadequate solution.  The reason being is such a set of criteria would result in more false positives than acceptable within their margin of error- meaning it would too often provide ‘verified’ responses when in fact the item was not legitimate.   

In fact, the authentication solutions used outside of pharma leveraged no less than a dozen different rules and data checks to determine, with the highest degree of certainty feasible, whether the unique identifier was legitimate.  Beyond the surface checks noted above, true authentication systems consider other factors such as request source, frequency and dispersion of requests over time, evaluation of traceability history relative to expected supply paths and, in some cases, even automated visual packaging inspections.

So, if these types of solutions exist and are used outside of pharma- in industries which have no regulatory requirements- why should the bar be set any lower in pharma?  Ah yes…. “Spirit of the law” vs “Letter of the Law”.

Now let’s address the risk that pharma companies face.  I certainly would not want to be the serialization lead at a manufacturer who is getting questioned why items, which ended up harming patients, were given the ‘thumbs up’ by their serialization system’s verification response.  If anything, I would want my systems to error on the side of caution- offering any number of false negatives over even a single false positive.  Of course, that’s the last thing wholesalers want to hear- as a spike in failed verifications means a major hit to their efficiency.  But back to the original point- “Spirit” vs “Letter”- is DSCSA in place to make sure the industry’s efficiency stays in tact or is it to protect patients?  So much focus has been on VRS and the battle between who’s VRS solution is better/faster/more widely used- but who’s paying attention to the actual content of the verification responses that will be flying all over the place- and more importantly the significant impact those verification responses have on the downstream flow of legitimate and illegitimate product.

Outside of the DSCSA text itself, guidance from other key organizations clearly indicates that the product identifier check is only one of the checks that should be done.  Over 2 years ago the FDA put out a guidance entitled “Identification of Suspect Product and Notification” (Link) which explicitly laid out several additional checks that should be done in order to determine if a product is suspect or not. (product sourcing, current supply/demand, visual appearance).  More recently GS1’s Verification Messaging standard (Link) did its best to ensure they are not liable for verification responses by stating “It should be noted that verification of product identifiers is only one element of ensuring security of products; further checks may involve physical inspection of the product and its packaging, including the integrity of any tamper-evident seals.”

So, you have some key organizations saying, “Yea the law requires you verify the product identifier but you reaaallly should do these other basic checks as well”.   Where will the industry fall?  “Spirit of the Law” vs “Letter of the Law”?

As always, maintain oversight of your serialization/traceability programs and ensure your implementation meets DSCSA verification requirements.   Challenge your vendors to provide hard evidence of how their systems are performing DSCSA verifications.   Manufacturers are now solely responsible for the verification responses they provide.

Jennason has the experience and solution offerings to help.  In addition to evaluating and testing serialization platform’s verification capabilities, Jennason also offers the DSCSA Verification Manager- a workflow solution ensuring companies complete all required verification tasks, retain required verification records and generate required FDA and trading partner notifications.  To Learn more, click here.

Sunday, January 13, 2019

What to Expect in 2019 (Caution: Marketing Material Ahead)

I hope everyone had a great holiday season and found time to spend with family and friends.   I am looking forward to a great 2019.

Towards that end I wanted to offer a few of my own personal insights for the pharma serialization space in 2019 followed by an update on new consulting, solution and service offerings from Jennason.

Predictions for pharma serialization in 2019

With the Nov 2018 DSCSA serialization milestone having passed the industry is in a unique position.   As more and more companies enter a fully serialized world, we will experience the first true test of how well implementations are performing.   

Some bumps have already been experienced- the question is whether it will become a trend?

Some bold predictions for 2019
1.    As the industry starts to tackle aggregation and integration with distribution/3PL operations (on a mass scale) the robustness of enterprise serialization platforms will be tested- and many will recognize their solutions are not up to par.
2.    The major players in the enterprise serialization space will see some shakeup-   with both current players losing steam and new players entering the mix
3.    The progression towards "value beyond compliance" will be slowed by efforts to resolve issues with current implementations

Jennason Consulting in 2019

As always Jennason continues to provide the pharmaceutical industry with expert consulting support and purpose-built solutions based on over 10 years of serialization and commercial supply chain experience.  

At the end of 2018 Jennason consulting engagements could generally be put into 3 categories:  
1.    Emerging biotech/pharma manufacturers looking to launch products in the next 12-24 months and needing to be serialization compliant.
2.    Manufacturers who have had an ongoing serialization project/program for 1+ years but need additional support to resolve vendor issues to ensure compliance with DSCSA is achieved.
3.    Manufacturers with an interest to extract further value out of their serialization investments- but to do so first need an assessment on the current state of their implementations.

Jennason looks forward to an intriguing 2019- the consistent goal remains the same- making sure pharmas are educated on serialization/traceability/compliance while promoting proper use of GS1 standards to ensure best, long-term implementations.

New/Updated Solution Offerings

Jennason Master Data and Workflow Manager- As a company's commercial supply chain demands grow so too does the importance of master data management.   The Jennason MD&W Manager provides a cost-effective and robust alternative to spreadsheets and manual processes.  More information

Jennason DSCSA Verification Manager- Last fall the FDA released guidance for Verification Systems under DSCSA.    The Jennason DSCSA Verification Manager provides a workflow for companies to ensure compliance with all required tasks (verification, quarantine, investigations) as well as manages required FDA and trading partner notifications.  More Information

EU FMD EMVO Gateway Translation Tool - Built in collaboration with Be4ward Consulting, the EMVO Gateway Translation Tool is geared towards companies needing an immediate EU FMD compliance solution.  The Tool is capable of translating serialization data files from packaging sites/CMOs into the EMVS format which can then be manually uploaded via the EMVO Gateway web portal.  More Information

Jennason Serialization Test Tool- Launched over 4 years ago the Serialization Test Tool continues to be the leading off-the-shelf testing solution specifically designed for pharma serialization implementations.  The Tool is capable of simulating common serialization scenarios (commissioning, aggregation, shipping, end of life) and generating the corresponding EPCIS test data.  All major L4/L5 serialization platform vendors are supported.    More Information

New Service Offerings  

In late 2018 Jennason launched Jennason Design Services.  The purpose of Design Services is to support companies in need of building custom applications which supplement or enhance their serialization and commercial supply chain operations. Design Service engagements range from developing implementation tools to reporting dashboards to proof of concepts for companies looking to unlock additional value from their serialization investments.    More information

Thank you again and look forward to hearing from you in 2019.

Monday, January 7, 2019

EU FMD: Leveraging the ‘EMVO Gateway’ option for manual serialization data entry/file upload to the EMVS.

With just over a month until the EU FMD deadline pharma manufacturers should be putting the final touches on their compliance solutions- most integral of which is how they will communicate serialization and related data to the European Medicine Verifications System.

For manufacturers of any significant size/scale this communication of data is being handled by 3rd party vendors who directly integrate with the EMVS.   This enables a largely ‘hands off’ approach for the manufacturers- as their product gets serialized at packaging sites/CMOs the data flows to their 3rd party vendor system who, in turn, re-formats and communicates to the EMVS (at least this is how it should work :))

Another, fairly under-publicized, option exists however- known as the EMVO Gateway.    The Gateway is a web user interface which manufacturers can access and perform all the necessary data communications to the hub.   The Gateway generally provides two options for uploading data- manual entry (via typing or scanning of a barcode into the web user interface) or file upload (uploading a pre-populated file)

The EMVO Gateway is an intriguing option for the following use cases:

  1. For companies whose 3rd party vendor is having issues and/or not on track to meet the upcoming deadline.
  2. Companies who wish to maintain a secondary (back-up/fallback) solution to reduce overall compliance risk or dependency on a 3rd party vendor.
  3. For companies who serialize product infrequently and/or at low volumes such that a more manual option is feasible.

A few key insights about the EMVO Gateway:
  1. The Gateway connection can be maintained in parallel to a 3rd party vendor connection.  Credit to the EMVO for recognizing that most manufacturers would see the value in having two connections enabled at the same time.  This means there is little to no risk (and cost) for a manufacturer to enable the EMVO Gateway as a backup option.
  2. The file formats which can be uploaded via the Gateway are NOT the same as files sent directly to the EMVS interfaces.  Don’t assume you can simply take files from your 3rd party vendor and upload them via the Gateway in case your 3rd party vendor fails.
  3. EMVO Gateway supports all necessary functions (master data upload, pack upload, pack update, batch update, recall, report requests).
Whatever the use case may be there are some key hurdles which must be cleared in order to properly register and initially set up the EMVO Gateway access- and even more importantly these tasks can be time-consuming.  To ensure your EMVO Gateway access is available come Feb.9 it is strongly advised that you begin the process ASAP.

If you need help getting access to your EMVO Gateway or have questions as to how the EMVO Gateway option may be best positioned in addition to, or in place of, a 3rd party vendor connection reach out to Be4ward for expertise.  Jennason is proud to have developed a solution in collaboration with Be4ward (Link) which ensures companies can use the EMVO Gateway option effectively and efficiently.

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