Tuesday, November 12, 2019

A few quick thoughts on the recent AmerisourceBergen letter covering 2020 serialization expectations...

Some quick thoughts on the recent AmerisourceBergen update letter covering 2020 serialization expectations…
  • ABC gives two options for meeting their saleable returns verification needs- maybe I’m reading too much into it but interesting to see the first option listed as EPCIS exchange and the second option as VRS.   Also, important to see that after the first option (EPCIS) is an “and/or”.    Why is this important?  If I’m a manufacturer I must recognize the scoping decision between putting focus on EPCIS data exchange vs VRS implementation.   For those who are already far down the VRS path this won't likely lead to a decision to scrap the concept all together- but this could have interesting impacts on those who are just now evaluating serialization vendors and are being presented with a hefty VRS price tag.   It’s important to re-iterate that, for some manufacturers, having EPCIS data exchange in place could alleviate the need for VRS (if you even need VRS in the first place-  See http://www.lifescienceserialization.com/2019/04/do-i-or-do-i-not-need-vrs.html)
  • “For those planning on sending serialized data, which implies that you are aggregating and your 3PL or distribution center can send EPCIS data….”  This is a seemingly straight forward comment, but it still gets confused often.  Certain serialization L4/L5 vendors have pushed a very bad (meaning risky) process of generating ‘shipping’ events with non-aggregated items. (Reach out if you’d like to learn why this is a risky process).  With more pressure to provide downstream EPCIS data exchange many manufacturers will recognize that just because their vendor generates shipping events doesn’t mean they're covered for EPCIS data exchange.  Unless you are fully aggregating you are better off not implementing data exchange with distribution/3PL, and therefore, with downstream customers, however, as this letter indicates the beginning-of-the-end for no aggregation is here.
  • "AmerisourceBergen is onboarding and testing now – and we must start receiving production data, via EPCIS 1.1 or 1.2 by May 1, 2020”    The time to get your EPCIS exchange capabilities in place is right now.  This raises interesting considerations for companies who are evaluating serialization vendors for the first time (or looking to switch). Up until this point emphasis was so often placed on picking vendors that could seemingly facilitate the ‘easiest’ integration with packaging sites/CMOs- now the equation must include who can best integrate with distribution/3PL and downstream customers- and that’s a very different equation.  Make sure to ask vendors for their experience integrating downstream data exchanges (using EPCIS) and make sure your vendors are in good standing with the distribution/wholesaler segment in general. (….but don’t worry most vendors are in good standing, it’s not like anyone went off and sued organizations in that segment of the industry….oh wait )
  • ...and on the topic of vendors… ABC urges manufacturers to consider their VRS provider- SAP ICH leveraging MediLedger.   Two key points here:  First, the very nature of VRS is that all providers must be interoperable- otherwise this doesn’t work for anyone.    However, we’ve already seen an enforcement delay and at least one of the reasons for that delay was due to inadequate progress (meaning vendors solutions not always working) when it comes to interoperability.  As such there is an argument that a ‘safe’ choice could be to select providers who are leveraging the MediLedger network.  The second key point is look more broadly then just ABC.   Across the Big 3 wholesalers a common characteristic is that all of them are using and/or piloting a VRS provider that leverages the MediLedger network.  (Note:  The decision to leverage MediLedger for VRS doesn’t mean you have to select SAP as your provider.  There are many VRS providers out there leveraging MediLedger)
  • Finally, ABC outlines their expectations for companies who do decide to initiate VRS testing and, ultimately, production use ahead of the now Nov 2020 deadline.   ABC recommends, smartly so, that manufacturers manage their use of VRS by uploading product GTINs into the lookup directory only when those products are ready to receive verification requests.    Second, and most importantly, ABC states “We will treat any negative verification responses as potentially suspect and quarantine and investigate per our internal procedures.”     This couldn’t be more clear- if you are a manufacturer and decide to turn on your VRS services, then any failed verification responses you provide must be handled through DSCSA-defined suspect and illegitimate product handling processes which (I’m a broken record on this point) are processes that all manufacturers must have in place today.  Make sure your suspect and illegitimate systems/processes are in place to handle the inevitable spike in failed verification requests that will occur as VRS use ramps up (https://www.jennason.com/dvm)

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