Don Tracy

HDA 2023 Traceability Seminar session, “GS1 Updates on Implementation Guides.” August 31, 2023. HDA 2023 Traceability Seminar, Washington, DC. Image Credit: © Nicholas Saraceno.

On the second and final day of this year’s Traceability Seminar, a session titled “GS1 Updates on Implementation Guides,” offered three individuals who spoke on resources for the industry to aid in Drug Supply Chain Security Act (DSCSA) readiness, expectations of trading partners, and more details. The speakers included:

Scott A. Mooney, VP, distribution operations, traceability, McKesson Corporation

Tracy Nasarenko, senior director, community engagement, GS1 US

Elizabeth Waldorf, director, global traceability and standards, TraceLink Inc.

The pharma industry community has leaned in together in order to solve how the industry as a whole can meet the requirements of the DSCSA. To offer more insight, the act requires the industry to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the US.

GS1 has designed the GS1 Lightweight Messaging Standard to support requests and responses forverification of product identifiers for serialized pharmaceutical products. Designed to support verification routing services (VRS) systems for DSCSA verification, it is intended to provide a simple lightweight messaging framework for asking questions and receiving appropriate information.

The team stressed the importance of having readable and scannable barcodes, sharing of master data, and accurate information. Regarding Electronic Product Code Information Services (EPCIS), all parties must be onboarded with customers and rely on standardized use to support interoperability.

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Pharma Commerce provides a synopsis of the presentation. 

HDA 2023 Traceability Seminar: GS1 Updates on Implementation Guides

HDA 2023 Traceability Seminar session, “Exceptions Handling: Mitigating Data Errors to Keep Products Moving.” August 30, 2023. HDA 2023 Traceability Seminar, Washington, DC. Image Credit: © Nicholas Saraceno.

Wrapping up the first day of this year’s annual Healthcare Distribution Alliance (HDA) Seminar, six industry leaders came together to offer various workshop recommendations, personal insights, and answer questions. Titled “Exceptions Handling: Mitigating Data Errors to Keep Products Moving,” the session featured Bruce Harold, director of EDI, KeySource, Arthi Nagaraj, head of analytics, strategic projects and serialization, Sanofi US, Tracy Nasarenko, senior director, community engagement, GS1 US, Maryann Nelson, regulatory manager, Cardinal Health, Inc., Jeff Primeau, VP, business solutions cencora, Integrated Commercialization Solutions, and Tim Stearns, senior director, industry relations, Healthcare Distribution Alliance.

This Q&A has been edited for clarity and brevity. 

Tim Sterns: This question is directed at Maryann and Jeff. Who in your organizations will be involved in handling the exceptions that are being given to companies on transitioning to the FDA’s new supply chain policies by Nov. 27, 2024?

They’re complex. They’re going to require coordination across multiple departments. For exceptions, a wholesale distributor discovers that through receiving regular distribution, we’re going to get that error message from our sterilization repository that they’re going to have to quarantine that product. They’re going to have to provide a general description of the error and perhaps supporting documentation. If it's missing for the entire shipment, maybe that’s the packing slip. That information needs to be relayed to the manufacturer.

Cardinal Health has formed a centralized exception team that’s going to coordinate these certifications. If we don’t have the right manufacturer contacts or the wrong contacts, we’re probably going to have to change our sourcing teams to get us where we need to be. Depending on the manufacturer’s response, our EPCIS support team will likely have to get involved to make sure corrected data is received. Even for mistakes, overages or shortages that are identified by our downstream trading partners, those are likely that originate in customer service. So, we have to be treating them as an example to ask for serial numbers so that the incident can be properly researched. The bottom line is you can't really operate in a silo. Many of these roles are going to require some level of technical expertise to be able to identify the cause and the appropriate corrective action.

I think it’s the bridge with the pharmacy discussion. If you take that perspective of how many people get involved, thinking about shipping, going to a pharmacist, and they encountered an overage, now they’re going to contact customer service. We’re going to have to figure out who it came from.

Stearns: What staffing levels do you anticipate? What will be needed in facilities? Could you speak to the importance of technical knowledge and experience?

When we talk more about what kind of expertise, I think you’ve heard quite a bit about how complicated exceptions can be, especially with it being at a centralized level. The concept of having to fix it within my four walls doesn’t exist anymore. You have to have it so that product can be traced through the supply chain. Therefore, there has to be that coordination between the different trading partners. It has a different added level of expertise because you definitely have that same expertise you need, but now, you’re getting into the technical aspects, understanding your systems and how you can fix it. That has to be coordinated with your quality systems and warehouse systems. That’s just the added level of expertise and coordination that’s necessary to handle exceptions.

We don’t exactly know what it is yet. What we are planning toward is hiring a couple of analysts who will regularly monitor exceptions. I’ll go back to the solution maturity piece. Right now, our solutions are not there, at least not all solutions are there, you know exactly what is failing or what's going wrong. There are a lot of things that we can do, but that’s what we are planning.

In terms of technical knowledge, it’s not just final EPCIS or B2B exchanges. There are so many interfaces within the company before we send that out to our customers. To be able to resolve these exceptions, you need a deep knowledge of master data sources that is causing the exception.

What number of root causes can lead to exception-level estimates fluctuating? Can you speak to the impact of what even a single error under the disguise of EPCIS can mean?

The simple answer is a single EPCIS problem can stop a whole file in any system. You think that the large shipments you’re doing is manufactured, especially to the Big Three. You start the whole file because of one error in the system, and as a result, there are a lot of products that needs to be corrected. Now unfortunately, if it's that type of problem, there's a better chance of seeing it up front, seeing before the product arrives there and being able to ask for records. Some other systems will be able to work around that. It may make it more complex to get a correction because if the whole file fails, quality may be affected.

What are you doing internally to handle exceptions? In contrast, what are manufacturers doing to handle exceptions compared to distributors?

A lot of different carriers have to know something about this process, and they know what to do, seeing their portion of it. We are focusing on receiving permission because the upstream process has to be controlled before we really get a good quality downstream process. With process improvements, we need to reduce the number of exceptions. To catch exceptions earlier in the process, we need to look into it. Obviously, early recognition and preventative measures are very important.

In this breakout session, industry leaders discuss understanding and overcoming errors brought on by data challenges. 

HDA 2023 Traceability Seminar: Mitigating Data Errors to Keep Products Moving

HDA 2023 Traceability Seminar session, “FDA Update: Enforcement Policies and Guidances.” August 30, 2023. HDA 2023 Traceability Seminar, Washington, DC. Image Credit: © Nicholas Saraceno.

was in attendance at the first day of this year’s HDA Traceability Seminar in Washington DC, and as part of the events breakout sessions, a specific conversation focused on updates from the FDA.

“FDA Update: Enforcement Policies and Guidances” featured Tish E. Pahl, principal, Olsson Frank Weeda Terman Matz PC, and Brian P. Waldman, partner, ArentFox Schiff LLP. In a joint effort, the two discussed new initiative being enacted by the government agency. Topics included:

Waivers, Exceptions, and Exemptions Final Guidance

Lessons from Safe Chain Warning Letter and Diamantstein Indictment

Effective as of Aug. 25, the Enhanced Drug Distribution Security (EDDS) compliance policy is considered a final guidance for trading partners under the requirements of the enhanced Federal Food, Drug, and Cosmetic Act (FD&C Act). According to the FDA, the policy is “intended to help partners guarantee access to prescription drugs as the supply chain transactions to the electronic product tracing at the package level under the Drug Supply Chain Security Act (DSCSA).” However, it was 

 that via Section 582(g)(1) of the  FD&C Act, FDA “does not intend to take action to enforce” rules on exchanging product transaction data, reporting such data to regulators, or verifying salable returns against transaction data (apart from existing methods of verification) until Nov. 27, 2024. Rather, a “Stabilization Period” lasting until that time will be enacted, which is intended to provide the pharma supply chain with more time to implement and troubleshoot their systems and processes. Currently, the agency expects companies to meet these requirements by Nov. 27, with the understanding that it may take longer for some organizations to prepare.

The discussion then turned to details of the Verification Compliance Policy. Revised from October 2020, it states that until Nov. 27, 2024, the FDA will not enforce:

Wholesale distributor verification of saleable returns

Dispenser verification obligations in suspect and illegitimate product investigations

Regarding Waivers Exceptions Exemptions (WEE), any manufacturer, re-packager, wholesaler, ordispenser has the ability to request a waiver under requirements that would lead to economic difficulties or for medical emergencies. Currently, the FDA can issue waivers on its own terms.

Closing out with a conversation on policy enforcement, the duo spoke about the consequences of not following updated guidelines. Issued June 8, a warning letter was sent to Safe Chain Solutions, LLC, in which the agency claims multiple DCSCSA violations resulted in the distribution of counterfeit Rx drugs. Only a few weeks later, criminal charges were filed against Steven Diamantstein, owner of wholesale drug distributor Scripts Wholesale, Inc. According to the indictment, Diamantstein allegedly purchased diverted drugs, including HIV medication via a “buyback” scheme.

Pharma Commerce provides a summary of conference breakout session. 

HDA 2023 Traceability Seminar: A Synopsis of FDA’s Enforcement Policies and Guidance Updates

team just returned from Informa’s Patient Assistance & Access Programs (PAP) show in Philadelphia, and as 

 by colleague Nicholas Saraceno, the event was featured as a component of the larger Access USA program. In addition to conducting videos interviews that can be found 

, our team was also in attendance for multiple breakout sessions.

“Patient Assistance for Gene Therapies,” featured Kevin O’Meara, VP of patient services solutions and Skyler Vise, senior director of client delivery and excellence, both with Eversana, a provider of commercial services to the life sciences industry. In a collaborative effort, they spoke on the “critical” need to create patient-friendly cell and gene therapy (CGT) programs, acknowledging that it will be expensive at the same time. Other points made in the discussion included:

Currently, it takes four to five years to diagnose a CGT patient. During this process, time should be used to develop patient support programs, especially given the high price tag.

Once CGT is ready, it’s important to keep a steady line of communication with the patient. Having minimal info could lead to a delay in treatment.

This type of therapy needs to be administered within 72 hours. If an appointment is cancelled, one must move quickly to coordinate a replacement. If no substitute is found, the product will go to waste.

Keep in contact throughout the process to ensure patient adherence.

Another seminar, “Understanding the Need for Patient Assistance Post-Inflation Reduction Act,” featured a panel consisting of Kevin Hagan, CEO of the PAN Foundation, George Valentine, patient and family advisory council member for the foundation, and Kelly Brantley, practice director for Avalere Health, a healthcare consulting firm, all of whom spoke on the impact of this reform.

According to Hagan, reforms will lead to a Medicare cap limit of $2,000 by 2025. In a PAN Foundation survey of 2000 individuals, three out of four believe this new cap will make it difficult for them to keep up with their medical bills. Additionally, 57% of respondents that have already hit their cap stated that they have had to cut back on food expenses.

Valentine finished the discussion with his personal experience. Diagnosed with chronic lymphocytic leukemia in 2002, the council member would hit his out-of-pocket from chemo treatments on a yearly basis. He stated that around 2016, his doctor reached out to him with news that he would be able to take one pill twice a day, significantly improving his quality of life. Despite the prospect of having a quality of life again, Valentine was challenged with another obstacle: the medication costing $16,000 a month. His doctor suggested getting in touch with PAN for support.

“If it weren’t for PAN, my quality of life would go down, and I would not be here today,” he says. “The PAN Foundation covering costs has helped me talk more about regular life, such as where I’m going to spend time with my grandson.”

Pharma Commerce offers a synopsis of some of the conference’s events. 

PAP 2023: A Summary of Unparalleled Strategies to Drive Access and Affordability 

Since the dawn of the COVID-19 pandemic, pharmaceutical organizations and their partners have been tasked with establishing new innovations to keep supply chains running as smoothly as possible. Refining approaches in “smart pharma” has been one area of focus. Those could include, for instance, the application of smarter data management and storage methods, to the increased use of data automation to offset strained resources in manufacturing and distribution. The goal is to continue to advance broader industry efforts in digitalization.

 recently connected with Samantha Betancourt, head of strategy and marketing at UPS Healthcare, to discuss the pathway for smart pharma in helping address current and future supply chain challenges.

Betancourt has more than 20 years of experience in areas such as global logistics planning, supply chain analytics, as well as various commercial and operational roles. Before joining UPS, she held the position of vice president, supply chain and external operations at Ortho Clinical Diagnostics. Her industry involvement has ranged across contract manufacturing, telecommunications, technology, pharma, and medical device.

It’s no secret that over the past few years, factors such as the pandemic and less manpower or reduced resources at certain journey points have impacted the clinical and commercial supply chains. What do you believe industry leaders in pharma, logistics, distribution, etc. can do today to eliminate some of these continued challenges—and find creative ways to keep these supply chains flowing consistently?

The pandemic revealed the healthcare industry’s overdependence on offshoring sources, equipment, and material goods. The dependency on far away cross-border sources combined with lower in-house and supplier managed inventories became an Achilles heel when rolling stay-at-home orders impacted production and border shutdowns impacted product flows. This led to an increased need for deep-frozen and cryogenic storage. Storage at these temperatures is not new for the logistics industry but will continue to be an important requirement in the coming years.

Here are some steps UPS Healthcare is taking to optimize our customers’ supply chains:

 Weather disruptions and geopolitical disturbances will continue to impact manufacturing and the flow of goods. Whether it’s labor disruptions, shifts in manufacturing, or the added strain on the global freight market, problems and pressures within supply chains will remain.

Enhanced costs and complexities of scale: 

The growing focus on sustainability, changing trade agreements, combined with growing demand will continue to put pressure on the supply chain. Shipping compliance and costs can be a major barrier to growth, especially as companies continue to expand globally.

 Visibility, chain of custody, and quality control continue to be crucial in the healthcare industry. As the cold chain grows to include more players responsible for smaller pieces, coordination and collaboration are increasingly critical.

 While the initial investments may seem daunting, reusable packaging cuts down on single-use waste and can drive significant cost savings and better performance.

Intensified efforts to de-risk supply chains: 

To avoid future risk, companies are actively seeking flexible alternative sources that are closer to home for their drugs and devices. These types of operations can reduce expenses and complexity. It shows in enhanced control over products, and in moderation of the financial impact of restrictions on shipping and deliveries. Simply being in the same time zone as production and shipping simplifies business and improves collaboration. This relocation, called nearshoring, isn’t simply theoretical. It’s happening now. Friendshoring or lowering dependency on countries with instability while growing manufacturing presence in countries with favorable government policies, will also continue to increase.

 As healthcare needs around the globe grow increasingly complex, specifically with such emergent new diseases and faster degrees of spread, the industry will need continuously more sophisticated transportation logistics and networks that can be quickly executed and enabled with a reliable quality management system to ensure quality throughout the chain of control.

Leading cold chain providers are investing in futuristic cold storage facilities, along with high-standard, sustainable, innovative packaging and new active and passive transportation technologies. These are critical components in ensuring that biologics, pharmaceuticals, cell and gene therapies, and other contemporary treatments can be safely and efficiently delivered to all corners of the globe.

 By improving supply chain visibility, industry leaders can gain a better understanding of their supply chain and identify potential challenges and disruptions early on in the process. This can help them to create improved efficiencies and proactively address issues before they become major problems to ensure a steady flow of goods and services in a timely manner.

How are innovations in digitization, analytics, and automation working to improve approaches in pharma technical development? How, in turn, can they help enhance the patient experience?

Digitization, analytics, and automation mean better patient outcomes, driven by continued innovation. Dealing with a global pandemic, and subsequent and more frequent natural disasters, the healthcare industry has continued to build upon what it’s learned by surviving these crises, which have provided a solid foundation to help future generations thrive in other areas.

Digitalization allows for the collection, storage, and analysis of large amounts of data that can be used to inform the drug development process. By analyzing data from multiple sources, companies can gain insights into patient preferences, outcomes, and unmet needs to develop drugs and treatments that better meet patient needs and enhance their overall experience.

With the help of new data, we are also seeing shorter cycles from development to deployment of new vaccines, therapeutics, and technology like cell and gene therapy to fight whatever comes next. Vaccine delivery continues to create long-term value in future access to new drugs, but only constant new investment in innovation will give patients around the world the medical access they need, when and where they need it.

Companies such as yourself are proponents of using smarter data analytics to provide a so-called smarter pharma experience. Can you elaborate on this concept of “smarter pharma”—is it basically about manufacturers applying technologies such as 5G, blockchain, sensors/AI, cloud, etc. across the product lifecycle?

The concept of “smarter data” refers to the application of advanced technologies and data analytics to the pharmaceutical industry to optimize drug development, manufacturing, and distribution processes, leading to an improved patient experience. UPS’ portfolio of solutions drives value to our customers by protecting critical healthcare shipments, whether they’re going across the country or across the world.

We continue to focus on smart pharma to enhance the overall patient experience. RFID and 2D barcodes are two items added to each package and throughout facilities to create a smart pharma network that allows for end-to-end visibility along with easy adaption to technologies currently developed for use within our facilities and transportation network. Both sensor technologies allow for all data (SKU, lot/batch, serial number, expiration, etc.) to be captured with one scan or a single movement to accurately capture all movement data.

UPS has deployed smart package smart facility (SPSF) technology for preloading RFID tags and scanners to 100 US facilities, will deploy this technology to another 500-1,000 centers in 2023, and are installing this technology on package cars as part of the second wave of the SPSF initiative, in 2023.

As far as automation specifically, with the emergence of more complex injectable drugs, gene therapies, and medical device combinations, is pharma packaging automation evolving fast enough to meet the growing demand? How are manufacturers and their partners meeting the higher regulatory requirements for packaging development?

The pharmaceutical packaging industry is rapidly evolving in terms of automation to meet the growing demands for complex injectable drugs, gene therapies, and medical device combinations. Automation in pharmaceutical packaging can significantly reduce the risk of human error, improve production speed and efficiency, and increase product quality and consistency.

As demands grow for more complex packaging, manufacturers and their partners are responding to the higher regulatory requirements for packaging development by investing in advanced automated systems and processes that meet regulatory requirements, as well as R&D to create new packaging designs and materials that can better protect drugs and medical devices from damage and contamination.

The first step to successfully transport critical biologics is to implement a packaging solution built around each customer’s temperature requirements and shipping route, including distance and time parameters. 

To what levels have your pharma customers and supply chain partners embraced the concept of smart data? How much are they incorporating it in their day-to-day activities?

Our healthcare customers rely on us to provide them with accurate, real-time, and smart data to help them make timely decisions to support their supply chain needs.

Proactivity is key to providing the best customer and client service. Having detailed information regarding the integrity of the shipment (temperature) before it arrives to the consignee allows our customers to be prepared if an issue arrives. Receiving smart data that notifies and provides information ahead of delivery (i.e., temperature data) solely benefits the customer, which lets them know if there is a disruption or issue with their shipment.

Predictive analytics on inventory, financials, and forecasting is an area we are reviewing to provide additional insight our customer’s need. Customers want to be fed information that makes sense and alerts them to what they need to do if there is a problem.

Q&A explores new opportunities to strengthen supply chain resilience—and build on the lessons learned. 



