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Deadline for Rx transaction data on horizon

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With the exception of wartime, concerns about the supply chain have never in living memory been more pressing than they are today. Americans, long accustomed to quick, easy access to relatively low-priced goods, have been confronted with a unusually high number of out-of-stocks since the arrival of COVID-19 and, based on the number of container ships currently stacked up outside major ports, the situation will continue well into 2022.

Pharmaceuticals are one sector that has, for the most part, avoided the disruptions that continue to constrain so many parts of the economy. Aside from a handful of high-profile exceptions — among them, personal protective equipment during the early months of the pandemic and hydroxychloroquine, the malaria treatment that former President Trump touted as a means of countering the SARS-CoV-2 virus — the health care supply chain has performed exceptionally well. That’s a tribute to the nation’s three big pharmaceutical wholesalers — AmerisourceBergen, Cardinal Health and McKesson — which handle the lion’s share of industrywide volume, their smaller counterparts, and business partners up and down the supply chain.

Their collective efforts to keep the drug distribution system operating at high levels of efficiency and accuracy are a prerequisite for success in the fight against COVID. The Biden administration’s renewed push to convince vaccine skeptics to be immunized and administer booster shots, together with plans to invest a billion dollars in increasing the availability of rapid at-home test kits, puts a premium on having the right health care products available in the right place at the right time. More broadly, the well-being of patients across the continuum of care depends on all parties doing what is needed to maintain and enhance the system.

As the findings of a recent survey conducted by the HDA Research Foundation indicate, this is an important moment for stakeholders in the pharmaceutical supply chain to remind themselves of that obligation. The report found that much must still be accomplished within the next two years to meet transaction data requirements under the Drug Supply Chain Security Act (DSCSA). The law mandated the development of an interoperable system to track and trace prescription medications, requiring transaction data with product identifiers to be provided with all medications beginning on November 27, 2023, a decade after President Obama signed the legislation.

The HDA Research Foundation survey, which included 52 drug makers, 21 distributors and five third-party logistics providers, states that 59% of manufacturers are not currently sending data to wholesalers. Furthermore, most distributors are not connected to manufacturers in production today, and no connections in a production environment currently exist with wholesalers’ dispenser customers. Many of those customers, the report adds, plan to use a portal managed by the distributor to access data.

Additionally, three-quarters of drug wholesalers identified a lack of trading partner commitment as the top obstacle to implementing GS1 Electronic Product Code Information Services (EPCIS), which, according to Food and Drug Administration guidance cited in the study, is the only widely recognized standard that allows supply chain partners to share data in a way that complies with DSCSA.

“Though the deadline for sharing transaction data is two years away, many health care supply chain trading partners are realizing there is work to be done to establish proper business-to-business connections; ensure data are formatted, transmitted and received successfully; that processes for troubleshooting are created; and that products in inventory have the right data attached to them for shipping after November 27,” says Perry Fri, executive vice president of industry relations, membership and education at the Healthcare Distribution Alliance and chief operating officer of the HDA Research Foundation. “The survey shows where trading partners are in the process of adopting EPCIS — and digs into what might be leading to slow implementation rates across the supply chain.”

Among the reasons for hesitancy cited by survey respondents were concerns about “past or potential future enforcement discretion” and the failure of distributors to establish clear deadlines for business partners to take action. Such reasons, coupled with fallout from COVID, have put the industry behind the eight ball.

The HDA Research Foundation report is a salutary reminder about the steps that must be taken to fulfill DSCSA’s promise of augmenting what is already the world’s safest and most secure pharmaceutical supply chain, and does so by implementing a single, nationwide standard that facilitates the movement of essential health care products, rather than a patchwork of unwieldy state-by-state regulations. It’s time for all of the companies that comprise the drug distribution network that patients across the country count on to get serious about the work at hand.


ECRM_06-01-22


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