A large distributor like AmerisourceBergen receives product from as many as 8,000 OTC and pharma companies. They break down most cases for outbound shipping, and every single unit of sale is hand-scanned—this is done in as many as 26 different distribution centers.
Distributors are faced with mitigating the impact of serialization on product flow through the distribution facility. They cannot depend on a system where a human is making decisions about how to manage each product as it moves through the facility; they must automate as much as possible.
One of the biggest issues facing wholesaler/distributors is their ability to depend on the accuracy of aggregation data. The e-pedigree data they receive from manufacturers must match what’s inside those cases—100% of the time. To do this, they must be able to rely on the concept of inference.
Because the stakes are so high and the impact to their business model is so profound, a consortium of wholesalers, along with some manufacturers and chain pharmacies, has been lobbying for national legislation that would preempt all state laws.
Pharmacies, clinics, and hospitals
Under most e-pedigree rollout plans, either state or proposed federal, pharmacies do not have to be ready until much later than wholesalers/distributors. Last in the California e-pedigree rollout plan, pharmacies do not have to be ready until July of 2017. This has caused much complacence.
Smaller pharmacies will struggle to find resources to invest in scanning and storing e-pedigree information. Many of these pharmacies will have to lean on their major distributors for help gearing up to meet requirements.
Pharmacies will eventually be required to have systems deployed that will be capable of receiving the e-pedigree information that wholesalers provide. Companies that have already mistakenly invested in pedigree technology and approaches that are not interoperable with those that the wholesalers select will be forced to invest further to be able to participate.
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