Since the Drug Supply Chain Security Act (DSCSA) was enacted nearly 10 years ago, healthcare supply chain stakeholders have made steady progress in meeting regularly (through HDA and other settings) to discuss compliance strategies, establish recommended guidelines and build consensus on key milestones.
Now, the industry is arriving at a critical inflection point as only one major deadline remains — November 27, 2023, when healthcare supply chain trading partners are required to exchange transaction data. These data include product identifiers for package(s) transacted in a secure, electronic, interoperable manner in accordance with standards published in FDA guidance. Currently, GS1 Electronic Product Code Information Services (EPCIS) is the only widely recognized international standard that allows supply chain partners to share transaction data.
While several other DSCSA milestones have been delayed due to FDA enforcement discretion, industry trading partners should not expect the same for the 2023 deadline. In fact, at HDA’s recent Distribution Management Conference, Leigh Verbois, the Director of the Office of Drug Security, Integrity and Response in the FDA’s Center for Drug Evaluation and Research, noted that there will not be an extension of this deadline. FDA is working at “full tilt,” Verbois said, and industry should be doing the same.
So, how are industry stakeholders advancing toward EPCIS adoption by 2023? To answer this question, HDA, working through the HDA Research Foundation, launched an EPCIS Implementation Benchmarking Survey. The Foundation’s inaugural survey gauges readiness among stakeholders, including manufacturers, distributors, dispensers and 3PLs; overall plans for exchanging DSCSA-required data; as well as perceived obstacles to implementation. A few key themes of the survey are highlighted below.
Few Trading Partners Prepared for 2023
As the Foundation’s findings reveal, few trading partners are prepared for data exchange via EPCIS in 2023. Of note:
- Only half of manufacturer respondents are in the process of establishing connections with distributor trading partners (with a connection defined as one that is “fully integrated and working in a production environment”).
- Many manufacturers (62 percent) plan to connect to trading partners directly, while 38 percent are planning to use a 3PL to manage downstream connections.
- More than half (57 percent) of manufacturers have no successful connections in a production environment today.
- Forty one percent of manufacturers are currently sending data to distributors.
- Most distributors are not connected to manufacturers in production today. Once EPCIS is implemented and data is being sent in production, half of distributors expect to have 70–250 connections, and a quarter plan to have between 350 and 650 connections.
- No production connections currently exist between distributors and dispensers. Many dispenser customers plan to use a portal managed by distributors to access data. For customers that plan to establish direct connections, distributors have shared their intent to connect to those customers in early 2023.
Most distributor respondents attributed the state of EPCIS readiness to a “lack of trading partner commitment,” while most manufacturer respondents attributed this to a “delay due to either past or potential future enforcement discretion.”
Time Is of the Essence
As noted earlier, the supply chain is entering a critical phase as it establishes connections and prepares to send DSCSA-required serialized transaction data in 2023. There are several key steps that should be completed before manufacturers can send data, including:
- Organizing data internally (for manufacturers);
- Transitioning to EPCIS 1.2;
- Onboarding with distributor and/or 3PL partners;
- Providing distributors with master data;
- Establishing and testing connections;
- Sending properly formatted data in a production environment; and,
- Determining processes to manage exceptions when errors occur.
Even though sending data with products is not required until November 27, 2023, each of these steps can reveal issues that can be time-consuming to resolve. For this reason, many healthcare supply chain trading partners have realized working ahead is a must — and they are tackling each of these pieces in earnest, knowing that FDA enforcement discretion is not an option right now.
To sum up, now is the time to have discussions with your service providers and trading partners to understand how you can prepare to set up data connections via EPCIS, especially if you do not already have a plan. There are only seven quarters left between now and the deadline. Based on lessons learned from those exchanging data today, EPCIS adoption is a complex process that requires both internal and external coordination to be completed successfully. Supply chain stakeholders will have an opportunity to discuss EPCIS implementation in detail at HDA’s upcoming Traceability Seminar, to be held November 1–3; learn more and register here.
The HDA Research Foundation’s EPCIS Implementation Benchmarking Survey was made possible through the support of AmerisourceBergen, Antares Vision Group, LSPediA and Two Labs. The Foundation plans to conduct follow-up surveys biannually (currently subject to funding availability).
The full survey results (including methodology and data tables) are available to download here.
For questions or additional information, contact Justine Freisleben at email@example.com or (703) 885-0277.
ABOUT THE HEALTHCARE DISTRIBUTION ALLIANCE
The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s nonprofit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.