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Founder and Principal Consultant at 1st Line Partners.

Counterfeit drugs infiltrating the US pharma supply chain through gray market channels underscore the urgent need for vigilance.

Caveat Emptor in the Gray Market

Healthcare providers must enhance awareness of counterfeit medicines to protect patients, especially as online drug purchases rise.

Raising the Alarm

Why taking proactive steps—and combing the right data sources—is critical to informed decision-making in risk management.

What Your Data Can Tell You About Illicit Trade Risk

Introducing a new Pharma Commerce column focused on combating illicit trade and protecting product integrity—and ultimately patients.

Welcome to the 'Dark Side'

As personalized medicine moves from innovation to mainstream, the burden of precision delivery falls on third-party logistics providers (3PLs) and carriers. These therapies are not one-size-fits-all—they are custom-built treatments based on an individual’s genetic makeup, lifestyle, and environment. The goal is maximum efficacy through highly tailored care.

What was once a standardized approach to medication is now an individualized therapy, and that transformation demands a delivery system as specialized as the treatment itself. Every shipment must arrive intact, temperature-controlled and on time because with personalized medicine, even minor lapses can compromise patient outcomes.

Unlike traditional medications, personalized therapies can't be quickly replaced if a shipment fails. Reproducing a customized treatment takes time—a delay that can be critical for patients often battling serious illnesses. For them, a missed dose isn't just inconvenient; it can mean a setback in treatment or a missed window for optimal effectiveness.

With the drug delivery industry continuing to grow, forward-thinking carriers are strengthening their chain of custody and increasingly adopting tools like predictive analytics, temperature-controlled packaging, and real-time tracking to keep shipments safe enough to withstand long-distance travel.

Below are some areas for providers and logistics companies delivering personalized medicines to consider.

Law aims to protect the integrity of medication

Protecting the integrity of medications, especially personalized ones, requires in-depth knowledge of industry legislation.

The Drug Supply Chain Security Act (DSCSA), enacted by the FDA regulation in 2013, was designed to safeguard the US pharmaceutical supply chain from counterfeit, contaminated, stolen, or otherwise harmful drugs. It helps protect patients from receiving incorrect or injurious drugs, enhances the security of our nation’s drug supply, and enables a more seamless flow of data between supply chain partners.

While this regulation applies to all prescription drugs, its importance is amplified when it comes to personalized medicine. Every product must be traceable, from manufacturer to pharmacy, using serial numbers and detailed documentation. Carriers must not only understand this legislation but actively ensure their systems and partners align with it to avoid breaches that could compromise patient safety.

Yet not all stakeholders fully comply, and I have experienced gaps in execution firsthand.

Challenges in home delivery of personalized medicines

A decade ago, a family member of mine asked that an injectable drug be delivered to her home. However, the driver left her mediation in the mailbox like it was a bill or a magazine, even though it was temperature-sensitive and should have been brought to the door. Medications like this one can become ineffective or unsafe if left in extreme heat or cold.

Although those delivering pharmaceuticals are better trained today, 3PL providers must ensure drivers are properly instructed so that they don’t drop custom-engineered treatments and dash. Major carriers have the necessary infrastructure to move medications within and between metropolitan areas, but it gets trickier and costlier when the carrier must deliver pharmaceuticals to rural areas and only has the time to make a handful of stops.

In this scenario, the company might outsource the delivery to an independent contractor. If so, the smaller delivery service must understand the importance of correctly delivering temperature-sensitive medications. Otherwise, the driver could place the delivery on the front porch, out in the elements, or in the mailbox like what happened with my family member.

And while all medications should arrive intact and on time, the stakes are especially high when the treatment is personalized and tailored to an individual’s specific health needs.

To prevent missteps like these, carriers should:

Review and reinforce contracts with third-party delivery partners.

Ensure all drivers are trained in handling temperature-sensitive treatments.

Conduct routine audits to maintain compliance and quality standards.

Tracking technology provides real-time visibility

Today’s packaging and tracking technologies give consumers real-time visibility into their deliveries, a major leap from the static updates of five to 10 years ago. Mobile apps, GPS tracking, and instant notifications now offer moment-by-moment insights into a package’s journey, while smart sensors monitor conditions like temperature along with shock and humidity, which are critical for sensitive items like personalized medicines.

Beyond just tracking location, modern systems also predict potential delays and proactively communicate changes, building greater trust and confidence. In a world where speed, safety, and convenience drive consumer loyalty, real-time transparency is an expectation rather than a luxury.

In addition to enhancing transparency, these technologies are crucial for protecting the integrity of sensitive shipments, especially personalized medications that demand controlled temperatures and careful handling.

Many medications require strict temperature control to maintain their effectiveness, potency, and safety. Proper packaging plays a crucial role in ensuring that these medications remain stable during storage and transportation. This might include passive cooling systems like insulated boxes with gel packs or dry ice, or it could even include active systems like refrigerated shipping containers that maintain temperature control. Other options exist—think smart packaging that contains temperature sensors and GPS tracking for real-time monitoring.

Medications that include vaccines, biologics, and insulin often become ineffective or unsafe when exposed to temperatures that are too hot or too cold. This is because fluctuations in temperature can cause chemical or structural changes that render them ineffective. Insulin, for example, must be stored between 36°F and 46°F because exposing it to heat or freezing can cause it to lose its potency, making it less effective for blood sugar control in diabetes patients.

To mitigate risks, carriers are increasingly using predictive analytics to anticipate and adapt to disruptions. Whether it’s a snowstorm or extreme heat, these tools help reroute deliveries and preserve medication integrity.

Ensure quality of care every step of the way

As medicine becomes more individualized, the expectations placed on the delivery infrastructure rise as well. Logistics providers are no longer just moving packages—they are delivering highly sensitive and patient-specific therapies that often represent a critical part of someone’s care plan.

Meeting this challenge means investing in better training, more advanced technology and stronger partnerships throughout the supply chain. It requires a culture of accountability and precision at every touchpoint.

Personalized medicine is redefining healthcare. To fully realize its potential, the systems that deliver it must be equally modern, responsive and reliable.

Tim McClatchy is Vice President of Life Sciences at Kenco.

The shift towards personalized medicine necessitates a specialized delivery system, placing significant responsibility on third-party logistics providers and carriers. These custom-built treatments require precise handling, as any lapse can compromise patient outcomes. The Drug Supply Chain Security Act emphasizes the importance of traceability and compliance, especially for personalized therapies. Advanced tracking technologies and predictive analytics are crucial for maintaining the integrity of sensitive shipments. As medicine becomes more individualized, logistics providers must invest in training, technology, and partnerships to ensure reliable delivery of patient-specific therapies.

As this medical approach continues to become more widely adopted, the industry must adapt to help provide precise, compliant, temperature-controlled delivery of highly individualized treatments.

How the Rise of Personalized Medicine Impacts Life Sciences’ Logistics

Sticker shock at the pharmacy counter has become an all-too-familiar experience for both patients and providers. The rising cost of prescription medications in the United States creates a growing obstacle for millions of people.

In 2022, more than 4,200 drug products experienced price increases (many of which were higher than the rate of inflation), compared to the 1,200 drugs that saw price increases the year before.

 For patients, this meant the average price of a drug rose 15% in 2022 up from 2021 which saw an increase of 11.5%. With over half of adults

 worried about affording their family’s prescriptions, today, patients are put between a rock and a hard place: pay out-of-pocket prices they can’t afford or walk away empty-handed.

Information from the Centers for Disease Control and Prevention found that 8.2% of adults (nearly 9.2 million people) aged 18-64 did not take their medications as prescribed in 2021.

 Among those studied, uninsured adults (22.9%) were the most likely not to take medications as prescribed to reduce costs. Creating a ripple effect, rising prescription costs lead to an increase in nonadherence measures, such as skipping doses, reducing doses, delaying prescription refills, or forgoing a fill altogether, which can become harmful, or even fatal, over time.

To address these challenges and mitigate medication abandonment, pharmacists can leverage a variety of tools and strategies that provide transparency, immediate access to savings and comprehensive patient support. Solutions, such as real-time prescription pricing tools, patient assistance programs, and digital adherence platforms, empower patients to better understand their medication costs, locate convenient pharmacies and take a proactive role in managing their prescribed therapies. Through a multifaceted approach, these tools can support providers and patients in deciding on cost-effective therapy options, which may significantly reduce out-of-pocket (OOP) costs and prescription abandonment rates, thereby improving the overall patient experience. These resources can help patients and providers make value-based decisions about treatment and help patients decrease their OOP costs, reduce their abandonment of prescriptions, and help patients have a better overall experience.

The rising challenge of prescription abandonment

Medication abandonment and nonadherence are particularly worrisome for patients with lower incomes.

It has been reported that patients from medically underserved areas abandon prescription medications used to treat diabetes, hypertension, and cholesterol-lowering agents at a higher rate (5.44%) compared to their counterparts at (4.77%).

Additional data from IQVIA states that the average out-of-pocket cost per retail prescription rose in 2023, further burdening patients to prioritize between vital medications and other essential expenses. Later findings indicated that when OOP costs exceeded $250, 69% of patients did not start therapy,

 but when OOP costs were less than $30, the abandonment rate was only 11%. Another report found that prescriptions subject to deductibles were twice as likely to be abandoned at the pharmacy counter, meaning people on high-deductible plans were opting out of taking their prescribed medicine.

 For those with chronic conditions, a study conducted by a research team from the University of Michigan found that higher OOP costs, sometimes by an increase of $50, resulted in lower medication adherence rates.

Any doctor can underscore the importance of taking medication as prescribed and the serious implications that may happen if a regimen isn’t followed. Unfortunately, when patients are burdened by costs, they may struggle to fully grasp the long-term value of their medications. Driven by the immediate need for financial relief, they may resort to difficult decisions, like skipping doses or self-adjusting their prescribed regimens, inadvertently diminishing the effectiveness of vital therapies. The long-term consequences of this pattern of nonadherence extend beyond immediate health risks. Nonadherence can lead to worsening symptoms and disease progression, prolonged hospitalization, and an increase in overall healthcare costs. In fact, reports indicate that the estimated annual cost of illness or disease caused from nonoptimized medication therapy was $528.4 billion.

Strategic approaches to enhance patient adherence

Patients face several unknown factors when they go to the pharmacy counter. Information about the costs, medication availability, the wait time to fill, and in some cases, a patient's insurance coverage of their prescriptions may not be the most affordable option. High copays, deductibles, and non-preferred coverage for certain medications should not be an obstacle to good health. To best address these challenges and improve patient adherence, pharmacists can advocate for a number of actionable strategies:

Leveraging real-time prescription pricing tools:

 Patients who receive access to real-time medication price estimates are better equipped to make informed choices and gain confidence in knowing what to expect at the point of sale. This level of transparency helps reduce uncertainty and can strengthen patients’ trust in the broader healthcare system. Pharmacies can work with healthcare vendors to provide inventory and pricing data to enhance the effectiveness of real-time pricing tools. With greater participation from pharmacies, more patients can access a comprehensive overview of their choices. When utilized, a pricing tool can potentially save patients up to 80% on the usual and customary price of their prescription.

Even patients with insurance may find prescription costs higher than expected due to high deductibles or co-pays. Pharmacists can recommend prescription discount cards as an alternative that provides lower prices and is often more affordable than the OOP expenses through some insurance plans. By offering a discount card as an alternative, patients may save significantly on medications, which can reduce the financial strain of insurance-based costs. Pharmacists can help patients compare the costs between using insurance and a discount card to ensure they are making the most cost-effective choice, especially for medications not covered under their plan.

PAPs offer relief to eligible patients struggling with medication costs, particularly those who are uninsured or underinsured. By covering the full cost of select medications for qualifying patients, these programs not only ease financial strain but also help bridge critical gaps in care. The benefits are clear: a 2025 study on patients with diabetes found that A1C levels and medication utilization were considerably improved for patients who could get high-cost medications through PAPs.

 Pharmacists ​​play an essential role in identifying patients who may qualify for PAPs, educating them about the programs available to them, and assisting with complex application processes. By actively promoting these key programs, pharmacists are directly positioned to improve access and adherence.

 A common tool for new product launches or to help patients manage high co-pays, manufacturer coupons provide direct discounts on certain brand-name medications at the pharmacy counter. Manufacturer coupons make otherwise expensive brand-name drugs more affordable and reduce the likelihood of abandonment at the point of sale. Pharmacists are at the forefront of informing patients about applicable manufacturer coupons, and their expertise ensures patients maximize these savings opportunities and proceed with their prescribed therapy.

 Co-pay programs help patients manage high co-payments for their prescriptions, making expensive therapies more accessible by capping the patient's OOP contribution. A recent HealthWell Foundation survey revealed that31% of seriously ill patients who were using charitable copayment assistance could not access their necessary treatment without it.

 This signals how essential these programs are for maintaining continuous, life-saving care. Pharmacists can identify when a patient's co-pay is unusually high and guide them to relevant co-pay assistance programs, reducing financial pressure on patients and fostering adherence.

 These are often the pivotal access point for underserved populations. Community health centers improve patients’ access to affordable medications, medication counseling, and adherence support, as well as direct dispensing services. Most importantly, these facilities address not only medication needs but also broader health and social determinants. Many community health centers offer sliding scale fees or discounted services, which help patients access necessary medications without having to choose between healthcare and other financial needs. Working within or alongside these centers allows pharmacists to extend their reach to vulnerable populations, ensuring patients receive the affordable care options they need in a supportive environment.

When deploying integrated patient support tools, everyone wins. If patients can access their medications at prices they can afford, adherence increases, creating healthier lives in the community. At the same time, as adherence increases, prescription volume for pharmacies increases, too. Patient loyalty and trust could also improve if more affordable prices are consistently offered at a patient’s preferred pharmacy.

A key component to these accessibility and affordability tools is in large part powered by awareness. In order to drive meaningful impact, we need to go beyond simply offering these tools, but actively promote them. Traditional insurance coverage for medications is not the only solution. Pharmacists and healthcare organizations can work together to educate their audiences about readily available healthcare affordability strategies, especially if a patient expresses concerns about the cost of their prescriptions at the counter. Grassroots efforts—such as partnerships with community organizations, public health campaigns, and multilingual resources—can further enhance awareness and access, especially in populations most at risk for nonadherence due to affordability challenges.

Technology is reshaping the future of healthcare by removing long-standing barriers such as time, high OOP costs, and unequal access to essential medications. When done thoughtfully, digital patient-centric solutions can transform the pharmaceutical industry shifting the focus towards stronger and more personalized care.

Alexandra Robertson is the Senior Vice President of Growth at Visory Health.

1. Bosworth A, Sheingold S, Finegold K, Sayed BA, De Lew N, Sommers BD. Changes in the List Prices of Prescription Drugs, 2017-2023. Office of the Assistant Secretary for Planning and Evaluation. October 6, 2023. 

https://aspe.hhs.gov/reports/changes-list-prices-prescription-drugs

2. Bosworth A, Sheingold S, Finegold K, Sayed BA, De Lew N, Sommers BD. Price Increases for Prescription Drugs, 2016-2022. Office of the Assistant Secretary for Planning and Evaluation. September 30, 2022. 

https://aspe.hhs.gov/reports/prescription-drug-price-increases

3. Sparks G, Kirzinger A, Montero A, Valdes I, Hamel L. Public Opinion on Prescription Drugs and Their Prices. KFF. October 4, 2024. 

https://www.kff.org/health-costs/poll-finding/public-opinion-on-prescription-drugs-and-their-prices/#:~:text=One%20Quarter%20of%20Adults%20Have,Those%20Who%20Take%20More%20Medications

4. Mykyta L, Cohen RA. Characteristics of Adults Aged 18–64 Who Did Not Take Medication as Prescribed to Reduce Costs: United States, 2021. Centers for Disease Control and Prevention’s National Center for Health Statistics. June 2023. 

https://www.cdc.gov/nchs/data/databriefs/db470.pdf

5. Minghui L, Harmon M, Wasson M, et. al. Abandonment of prescriptions in medically underserved areas: Abandonment of prescriptions in medically underserved areas: Primary medication non-adherence in community pharmacies in the delta region of the United States. 

Exploratory Research in Clinical and Social Pharmacy

6. Devane K, Harris K, Kelly K. Patient Affordability Part Two. IQVIA. May 18, 2018. 

https://www.iqvia.com/locations/united-states/library/case-studies/patient-affordability-part-two

7. Deductibles and Coinsurance Drive High Out-Of-Pocket Costs for Commercially Insured Patients Taking Brand Medicines Pharmaceutical Research and Manufacturers of America. November 14, 2022. 

https://phrma.org/resources/deductibles-and-coinsurance-drive-high-out-of-pocket-costs-for-commercially-insured-patients-taking-brand-medicines

8. Reynolds EL, Burke JF, Banerjee M, Kerber KA, Skolarus LE, Magliocco B, Esper GJ, Callaghan BC. Association of out-of-pocket costs on adherence to common neurologic medications. 

9. Watanabe JH, McInnis T, Hirsch JD. Cost of Prescription Drug–Related Morbidity and Mortality. 

10. Cherry M, Cryder B. Impact of medication assistance programs in pharmacist managed patients with diabetes 

11. Peppercorn J, Hasler JS, Hu B, et al. National survey of financial burden and experience among patients with cancer and autoimmune disease receiving charitable copay assistance. 

Prescription medication costs in the U.S. have surged, creating significant barriers for patients, particularly those uninsured or with high out-of-pocket expenses. This has led to increased medication nonadherence, with serious health and economic consequences. Pharmacists can play a crucial role in mitigating these issues by utilizing tools like real-time pricing, discount cards, and patient assistance programs. These strategies can enhance medication adherence, reduce financial strain, and improve patient outcomes. Awareness and education about these resources are essential to maximize their impact and ensure equitable access to medications.

As the rising cost of prescription medications in the United States becomes an increasing barrier for millions of people, how can we effectively address and improve patient adherence?

Addressing the Threat of Prescription Abandonment

Using Data Loggers and Cold Chain Tech to Power Precision Pharma Delivery

, Heather Zenk, Cencora’s president of US supply chain, describes how today's distribution networks must seamlessly connect manufacturers to care sites that range from large academic centers to rural pharmacies and physician offices. This “last mile” delivery is essential because, as Zenk notes, “all healthcare is local.” Patients want access to advanced therapies close to home, and distributors play a critical role in making that happen.

A major focus in this effort is maintaining product integrity, especially for cold chain items that must be stored between 2–8°C. Innovations in cold chain management now go beyond temperature tracking; they include predictive maintenance of infrastructure such as freezers and compressors. Distributors not only monitor product temperature but also evaluate the performance and potential failure risks of the equipment that manages the cold chain environment.

Zenk emphasizes the importance of marrying manufacturer data with real-time logistics. For example, if a care site accidentally stores a cold chain product outside the optimal range for a short period, data from the manufacturer can often confirm whether the product remains viable. This responsiveness supports safe patient care and reduces waste.

Another important innovation is the use of reusable cold chain totes, which service over 90% of the US market. These require robust freezing systems and operational oversight to ensure readiness and reliability. Zenk underscores that preventing failure, rather than simply reacting to it, is the next frontier in pharmaceutical distribution. By using data-driven insights and predictive engineering, the distribution process becomes more resilient, ensuring that patients can access vital therapies without delay or compromise.

She also comments on the advanced technologies that are proving most effective in enhancing real-time visibility and operational efficiency; strategies organizations should prioritize to ensure compliance while minimizing disruptions for manufacturers and providers as the DSCSA compliance date approaches; lessons learned from recent drug shortages and global disruptions; the practical steps that can be taken in transportation, packaging, and warehousing to meet sustainability goals without compromising reliability or cost-effectiveness; and much more.

What advanced technology or data-driven solutions are proving most effective in enhancing real-time visibility and operational efficiency?

You can use binary data loggers, which might be in a, I'm moving a large quantity, a large quantity from point A to point B. Maybe I'm moving something warehouse to warehouse, so you can have a binary tracker. We use tools like Sensitech. We use data feeds—loggers that are feeding a system so that we can look at from end to end. We also are really tracking with third parties when we're using next-day air freight.

When I'm putting a very sensitive, high-dollar specialty pharmaceutical for an oncolytic or for a retinologist into the airspace, tracking that packaging in near real time with our third party also really matters. We know when it's in the air, when it gets to a hub, when it gets sorted, when it gets on a truck, and that entity in instance, really, the value that Cencora brings, is we're doing all of that in a 12- to 14-hour period of time. From the moment that I'm putting it into a cold chain pack out inside a cold chain refrigerated asset to track that package, all the way through to the site of care getting it, is under an 18-hour window to 24-hour window.

We know our cold chain materials have been qualified, certified, and we're doing all of that high quality work to know that can stay from 2-8°C up to 48 hours, up to 36 hours. We have different conditioning packages that last for different durations so we can meet the need. If I'm going to Guam, for example, we have to go to Guam. There's patients in Guam that we service. We know we need a 48-hour pack out there, so making the right cold chain asset match the service that we need is some blocking and tackling you just have to be able to do in the pharmaceutical supply chain in today's world.

In the second part of her Pharma Commerce video interview, Heather Zenk, Cencora’s president of US supply chain, explores how public-private collaboration, smarter sourcing strategies, and long-term manufacturer support are helping to fortify pharmaceutical supply chains against future crises.

How Predictive Maintenance and Localized Distribution Are Shaping Pharma’s Future

, Heather Zenk, Cencora’s president of supply US supply chain, describes how today's distribution networks must seamlessly connect manufacturers to care sites that range from large academic centers to rural pharmacies and physician offices. This “last mile” delivery is essential because, as Zenk notes, “all healthcare is local.” Patients want access to advanced therapies close to home, and distributors play a critical role in making that happen.

As pharma products become more complex, how is the distribution strategy evolving to ensure timely, safe, and compliant delivery? Alongside that, what innovations in cold chain technology are setting the standard for ensuring product integrity across these complex distribution networks?

We're sitting between the manufacturers and the sites of care, and we really see ourselves as the connector. I'm connecting access from a manufacturer's new and innovative therapy to a site of care, and that site of care could be an independent pharmacy in a small rural town, all the way to a large academic medical center in a huge urban area, to a physician- based office. We really look at all sites of care, because realistically, all healthcare is local.

You don't go outside of your community to receive care. You like to see your physician at the grocery store. You like to see your pharmacist around town. It provides comfort, it provides the realness of human connection. We really take it seriously that we're connecting new therapeutic ways to the sites of care. And with that, it's how do we make sure their product is viable? With a lot of the sustainability and new products that are coming to market, we need to keep in 2-8°C, which, for the common person, is refrigerated. We also want to make sure that we have a way to track that. The manufacturer would know when they develop it, what the exclusion is, so if it gets to 9°C, how long can it be at 9°C, and still viable if it gets to 1°C?

But realistically, if you keep it in 2-8°C, the expiry date that's on the package would be the therapeutic window that a site of care could deliver it. A lot of what we're doing is trying to connect—as we tend to do every day—the data with the time. If by chance, a site of care would call to say, “oh shoot, I got that cold chain product. It's sitting on my shelf. I didn't notice it. It's probably been about two hours, is it still okay if I give that to my neighbor, my friend, my patient?” Most of the time, we have data from the manufacturer that can say that's viable. It can be out of this window. Then two, we're taking seriously inside our four walls. It’s monitoring the temperature, yes, but it's also monitoring the equipment that manages the temperature. Think of it as, and this is non-sexy stuff for supply chain, but compressors, think of it as HVAC units. Think of it as the entities that are running our freezers that have the basic material that goes into our reusable totes that we use every single day. We have reusable totes that are driving 90-plus-percent of the US market. How do we freeze those? If a freezer’s equipment is going to fail, it's us understanding this compressor is now at 70%, and we should have someone either fix it, look at it, stop it, or understand the risk that we have.

Monitoring temperature is table stakes. You have to be able to do that. It's now how do I anticipate if a piece of equipment is going to fail? Does that piece of equipment need a preventative maintenance check by a maintenance team member? Setting those types of things up as much as we can to eliminate equipment failing or anticipate when it might and take those signals. I don't think I would have thought about doing that as a as a pharmacist, but we all think about our home life. Your refrigerator fails at the worst possible time. How do we stop that? What types of engineering things can we look at to eliminate that? And that's really where we're going—from a tactical positioning—so we don't have large failures. And two, I think it's also connecting manufacturers’ data from how they develop a product, how they get it to finish dosage, where do they take it?

In the first part of her Pharma Commerce video interview, Heather Zenk, Cencora’s president of US supply chain, explores how public-private collaboration, smarter sourcing strategies, and long-term manufacturer support are helping to fortify pharmaceutical supply chains against future crises.

Balancing Compliance and Supply Chain Continuity

As the DSCSA enforcement date approaches (Aug. 27 for wholesale distributors), what strategies should organizations prioritize to ensure compliance while minimizing disruptions for manufacturers and providers?

Our strategy and mindset has been that this isn't going to happen overnight, and we all know that—God bless, you've been working on this for 10 years, and we've gone through the gamut of what technology are we going to use? We need some underlying capabilities, data like GLNs. How do you how do we identify a location standardized? How do we use GS1 global standards to do the standardization of packaging? Once we kind of started to get through, okay, what are the key building blocks we need? From a technology point of view, how do we identify sites of care? How do we identify the product, and then how do we start to track it and move it through the network?

Our strategy has always been we take federal particularly, and state regulations, very seriously. We pride ourselves at Cencora on we follow all state and regulatory laws. We also like to highlight where there might be risks, so working across the industry has been key for us too, working with the regulatory agencies at FDA, at the state boards of pharmacy, at EPA, DEA, a lot of the entities that tend to regulate—to let them know where there may be gaps or opportunities for them to lean in to help the industry comply.

As we get into Aug. 27, we're really looking at, how do we keep the supply chain moving? How do we also comply with the law at the same time and make those two strategic pillars not conflict? We're really using the tools that are in the toolkit of DSCSA, and one of them is the waivers and exceptions. We have been very transparent with our manufacturer partners, with the FDA, and sharing where we have data gaps. We've worked with the manufacturers for 10 years to say, serialize the product. Now let's talk about the data and the data accuracy.

First it was just getting a serialized data file—an EPCIS record—from the manufacturer. Then it became, are the records accurate? Let's start to match the physical product scans to the data. Then it became the timing of the data. Is the data coming? when is the product us coming to the warehouse? We have an ability to process it and move it in the supply chain. We're really looking at keeping the supply chain moving, using the waiver and exemptions as a way to say, we have some manufacturers that struggle with accuracy of data still. For those, can we get a waiver and exception, so we know it, and we're saying it to the market, but we're continuing to move the product. Then, how do we also educate the sites of care, all of the pharmacies, all of the hospitals, all of the clinics on this is what you need to do. How you do it is your choice from your regulatory support, but these are the three tasks that you need to do.

How do we work together t say, this is how you access the serialized data? This is how you now initiate a return, so we take our point in place in the education really seriously. Our whole goal is to keep the product moving, keep compliance top of mind, and front and forward. And if we can keep those two things going, I think for us, huge success.

I will also say this started kind as a burden and a regulatory thing. I think a lot of the market has said the US supply chain is the safest supply chain on the planet. We really looked at it as this is a way you transform the pharmaceutical supply chain. The connections we have with the manufacturer, we didn't have as connections 10 years ago. Healthcare system didn't use GS1 global standards, and now we are. This has really elevated, whether I think we want to admit it or not, it's elevated the connection between the trading partners. It's elevated a standard way to transact, and it's really made the supply chain more robust, more secure, and stronger. I'm not sure we thought that started when we started this. It's interesting to see the outcome of this.

In the third part of her Pharma Commerce video interview, Heather Zenk, Cencora’s president of US supply chain, explores how public-private collaboration, smarter sourcing strategies, and long-term manufacturer support are helping to fortify pharmaceutical supply chains against future crises.

The European Union intends to impose a 30% tariff on US imports valued at $117 billion if a trade deal is not reached, and if President Trump ends up enacting that same rate on the EU at the beginning of next month, per 

 Items include cars manufactured in the United States, bourbon whiskey, and Boeing aircraft.

The EU plans tariffs on various US products into one bundle.

EU considers anti-coercion measures and retaliatory action

Although it hasn’t been activated as of this time, the idea of invoking the EU’s anti-coercion instrument (ACI) has been circulating, which would come into play during a no-deal scenario. According to Crowell & Moring LLP,

 “the ACI provides a legal framework for a centralized and structured EU response to third country “coercion” through diplomatic means and, failing that, through any counter measures deemed necessary. The ACI states that one of its objectives is to ensure its responses are always in strict adherence to internal and international legality.”

US pushes reciprocal tariffs amid global trade shifts

In essence, if a deal isn’t reached, the EU could consider launching various retaliatory actions—via the limitation of US investments and taxes on US tech companies. A majority from EU member states would be needed, however.

The United States has requested a “near-universal” tariff on EU goods higher than 10%, with exemptions pertaining to various medical devices, aviation, some medical devices, manufacturing equipment, some spirits, and generic medications.

This comes as the US finalized an agreement with Japan requiring American importers to pay a 15% reciprocal levy on Japanese exports to the United States, including autos and their parts.

Pharma prepares for tariff-driven reshoring

Meanwhile, the pharmaceutical industry continues to prepare for levies by the beginning of next month, which could coincide with the planned reciprocal tariffs rates that were previously set.

Trump has described it as being a “low tariff” that would slowly increase over the course of approximately a year, with a tariff reaching up to 200% still being a possibility. Import taxes are vital, says the US president, to not only help guide the reshoring of manufacturing efforts back to the United States, but also contribute to financially supporting the “Big, Beautiful Bill” that he had signed on the Fourth of July. The bill builds on the 2017 Tax Cuts and Jobs Act, making most tax reductions permanent while raising funding for border security, defense, and energy production.

The European Union plans to impose a 30% tariff on $117 billion worth of US imports if a trade deal is not reached, mirroring potential US tariffs on EU goods. The EU is considering using its anti-coercion instrument to respond to US actions. The US seeks reciprocal tariffs on EU goods, excluding certain sectors. The pharmaceutical industry is preparing for potential tariffs, with companies like AstraZeneca reshoring manufacturing to the US. AstraZeneca plans a $50 billion investment in US drug manufacturing and R&D, emphasizing innovation and domestic supply chain strengthening.

Meanwhile, President Trump continues to push reciprocal levies and reshoring efforts, while pharma prepares for escalating costs.

Sean O’Hearen, 1st Line Partners

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