Survey finds more trading partners are exchanging electronic product information

Regulatory NewsRegulatory News | 01 March 2023 |  By 

[Editor's Note: This article has been updated 3 March 2023 to clarify HDA's role in conducting the survey.] 

The pharmaceutical industry and its trading partners have made “significant strides” in sharing transaction data with each other, which is a key element in medicine traceability mandated by the Drug Supply Chain Security Act (DSCSA). Yet there are still barriers to exchanging this data, according to a recent survey by the Healthcare Distribution Alliance (HDA).
 
The survey on manufacturer and distributor readiness addresses trading partners’ uptake of product identifiers using EPCIS (Electronic Product Code Information Services), a GS1 Standard for their data exchange, and captures data for the third quarter of 2022. 
 
The law mandates that all supply chain partners track their products through the supply chain and share information on transactions; such data must be exchanged in a fully interoperable way with all trading partners, and data must be kept for 6 years. The law requires these exchanges go live by 27 November 2023.
 
The survey was distributed to 45 manufacturers, 18 distributors, four repackagers and four third-party logistics (3PL) providers.
 
The survey found that 88% of all trading partners have already transitioned to EPCIS 1.2, the minimum version of the standard required for secure, electronic, interoperable exchange of data. Yet significant progress has been made from a previous survey conducted in the second quarter of 2020 which found that roughly half of trading partners reporting they are exchanging EPICIS data with each other. (RELATED: Pharmaceutical trading partners lagging in exchanged electronic product information, Regulatory Focus 24 September 2021)
 
Manufacturers said the top three reasons for not implementing EPCIS are employee resources, lack of trading partner understanding of the system requirements and the time to onboard trading partners and the IT commitment.
 
Thirty-one percent of survey respondents report they are seeing the benefits of EPCIS adoption while 37% report it is still too early to see the advantages.
 
The survey also shows that an increasing number of distributors are establishing connections with manufacturers. Over the last quarter, the number of distributor connections has grown from 2,434 to 2,930 with small and medium-size suppliers, while for large manufacturer, the number of connections has moved from 1,547 planned connections to 1,140. However, distributors “have shown signs that they are moving steadily away from planned connections to completed.”
 
The number of in process or completed connections from the first and second quarter jumped from 17% to 22% for small and medium-size suppliers and 29% to 56% for large suppliers.
 
Overall, while trading partners have made “significant strides” in adopting EPCIS and connecting to partners, “there are still major hurdles to overcome in the months ahead. Industry stakeholders must come together to address lingering obstacles identified, such as a perceived lack of trading partner understanding, commitment and engagement in the process of exchanging transaction data. There is also the issue of manpower and intellectual capital as the gaps in the IT workforce and employee resources continue to be problematic.”
 
HDA survey
 
 
 

 

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Tags: DSCSA, EPCIS, FDA

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