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These innovations are revolutionizing pharmaceutical packaging by enhancing drug safety, combating counterfeiting, ensuring regulatory compliance, and improving patient adherence across the supply chain.

Smart Packaging in Pharma: Driving Adherence and Safety Through Digital Innovation

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'

Despite challenges surrounding communication overload, drug shortages, and cybersecurity risks, this term is revolutionizing medication management and patient care through the use artificial intelligence and predictive forecasting. 

The Digital Transformation Reshaping Hospitals and Medication Management

Peer Exchange: Leveraging Technology to Strengthen Pharma’s Fight Against Counterfeits (Episode 6

 roundtable discussion, Nicholas Saraceno, editor of 

 and the peer exchange’s moderator, introduced a discussion on the pharmaceutical supply chain, highlighting its complexity and importance in delivering medications safely and efficiently from manufacturers to patients. The conversation explored the roles of various stakeholders, the need for supply chain resilience and quality control, and the growing importance of data management in achieving these goals.

The pharmaceutical supply chain is a multi-stage system encompassing: research & development; manufacturing; distribution: pharmacies and healthcare providers; and patients.

This system plays a vital role in supporting both individual and public health. It ensures patient safety by maintaining drug quality, authenticity, and regulatory compliance. Additionally, it supports public health by providing consistent access to essential medications and vaccines. During times of crisis—such as pandemics, natural disasters, or supply disruptions—the supply chain becomes even more critical for delivering life-saving therapies and maintaining stability. Efficient supply chain logistics also contribute to cost control,

helping reduce healthcare spending and improve the affordability of medications.

Ultimately, a resilient, transparent, and well-managed pharmaceutical supply chain is foundational to maintaining global healthcare systems. It ensures that patients receive the medications they need when they need them, and that providers and manufacturers can work collaboratively to meet evolving challenges in healthcare delivery.

The panel consisted of Dave Malenfant, an expert that specializes in optimizing the supply chain through innovative solutions for people, processes, and technology; Opeyemi Odusami, a seasoned professional with over 12+ years of experience and 10+ years at Sanofi; and Bob Celeste, Founder, Center for Supply Chain Studies, and Executive Director, Open Credentialing Initiative (OCI).

Each expert brought distinctive perspectives on the value of the pharmaceutical supply chain, including techniques for resilience.

Malenfant highlighted offers a holistic, circular model defined by seven stages: plan, source, make, deliver, sell, sustain, and return. This perspective emphasizes the importance of viewing the supply chain as an interconnected system, where resiliency depends on maintaining strong links across all stages. Each segment can have its own strategy, but the key is ensuring smooth, uninterrupted flow of both materials and data from end to end. Disruptions—such as current hospital drug shortages—often reflect failures at earlier stages, like sourcing or manufacturing. For instance, many shortages stem from the inability to obtain active pharmaceutical ingredients (APIs), which then ripple down the chain. He encouraged the audience to think of resiliency not just as a concept, but as an ongoing process of identifying weak links and implementing strategies to strengthen them, thereby ensuring the continuity and stability of the entire supply network.

Odusami added that supply chain resiliency involves not only responding to crises but also anticipating and preventing them. In addition to maintaining a synchronized supply chain—from purchasing and manufacturing to logistics and distribution—companies must build adaptability into their systems. This means being prepared for disruptions while also using data and planning to predict future issues. A resilient supply chain ensures continuity in drug delivery to patients, even during crises. Aligning all parts of the supply chain is key to maintaining consistent access to medications and protecting public health in the face of unexpected challenges or shortages.

As for Celeste, he noted that as more regions like the United States and Europe adopt product serialization, data and product misalignment has become a growing challenge in the pharmaceutical supply chain. In the US, such mismatches often result in products being placed in quarantine, with limited time and space to resolve the issue before the product is returned or removed. A key aspect of supply chain resiliency is the ability to efficiently manage these exceptions to avoid disruptions. Since serialization errors can escalate quickly, developing systems to handle data alignment and resolve issues promptly is critical to keeping products moving through the supply chain.

The panel also dove into risk mitigation; the handling of drug shortages, and crisis management; ensuring product quality across global manufacturing sites; dealing with counterfeit products; the Drug Supply Chain Security Act (DSCSA); the importance of a developing a deep talent pipeline; sustainable practices; and much more.

In the sixth part of this roundtable discussion, subject matter experts discuss how serialization, traceability tools, and multi-layered authentication technologies are becoming essential to proactive quality contingency planning, as counterfeiters grow more sophisticated.

Peer Exchange: Leveraging Technology to Strengthen Pharma’s Fight Against Counterfeits (Episode 6)

Balancing Awareness and Assurance

, Sean O’Hearen, founder and principal consultant at 1st Line Partners, discusses the critical issue of substandard and falsified (SF) medicines and the lack of awareness among healthcare professionals (HCPs). Despite SF drugs posing a growing global health risk, only 2% of HCPs are trained to detect them, and over 80% don’t consider them a serious threat. The Johns Hopkins Bloomberg School of Public Health has recently started focusing on this issue, holding its second symposium on the topic with support from Pfizer. Their work is encouraging, signaling that academic institutions are beginning to address these systemic educational gaps.

O’Hearen notes he’s not an expert in medical or pharmacy education but emphasizes that the BESAFE report—referenced in the interview—offers actionable recommendations. These include integrating SF medicine awareness into undergraduate curricula for healthcare students, establishing dedicated modules in medical schools, and expanding continuing education for practicing professionals. In his experience, frontline education, especially at infusion centers administering life-saving treatments like oncology drugs, plays a critical role in identifying and preventing counterfeit drug use. Nurses and healthcare workers trained to detect signs of falsification are a vital line of defense.

Efforts are underway globally, with the World Health Organization and the International Pharmaceutical Federation leading collaborative projects with African universities in countries like Nigeria, Uganda, and Tanzania. These efforts aim to establish standardized, research-backed curricula to address the growing threat of SF medicines, especially in regions more vulnerable to drug fraud.

While progress is being made, O’Hearen believes the issue is still in its early stages of recognition and response. With more academic and clinical institutions like Johns Hopkins stepping up, the hope is to eventually embed SF medicine detection and awareness into formalized education systems worldwide—closing critical gaps in the healthcare supply chain and improving patient safety.

He also comments on how the private sector should support and scale these efforts to ensure that HCPs globally receive standardized training; the communication strategies stakeholders should adopt to alert without alarming, ensuring patients stay confident in genuine pharmaceuticals, while also remaining vigilant against counterfeit threats; and much more.

What communication strategies should stakeholders adopt to alert without alarming, ensuring that patients stay confident in genuine pharmaceuticals while also remaining vigilant against counterfeit threats?

Be aware that there's a risk, and then be careful where you're acquiring your medicines or any products. And be aware, especially if somebody is using a medicine regularly. Let’s just say regardless of where you acquire it from, if you're using a medicine, you're going to notice when something is off, even though a trend we certainly see in this business is that the counterfeiters are getting more and more sophisticated, where even trained people on product integrity teams have a hard time just on initial visual inspection, telling that something is counterfeit.

I've had many times in an exercise in the lab, or where one of my colleagues says “hey, see if you could tell which one is counterfeit,” and you can't until you get into the detail of security features or forensic analysis. That being said though, a lot of times, just be sensory aware, If you notice the color of the pill is off, or you notice it doesn't smell right upon opening the container, or you notice the packaging looks different—there are some obvious telltale signs to know about.

I think it’s just generally knowing whether you're a patient, whether you're a healthcare professional, whether you're law enforcement, just knowing that this is a possibility, that this could be one explanation for something that seems off. And going back to how to report it—it's, being aware that it could be a problem. Be careful where you're purchasing. If you're purchasing at one of the big pharmacy chains, there's very low probability that you're going to have a problem, but if you're purchasing in some parts of the world, such as going across the border to Mexico for your medications, caveat emptor. Buyer beware. Just be aware. Be aware of where you're buying from, and assess the risk level of that.

In the final part of his Pharma Commerce video interview, Sean O’Hearen, founder and principal consultant at 1st Line Partners, offers communication strategies for staying confident in genuine pharmaceuticals while also remaining vigilant against counterfeit threats.

The Hidden Challenge of Reporting Counterfeit Medicines

Why has the underreporting of falsified medicines been such a prominent issue?

I think there's a very significant issue related to under reporting. Obviously, it's connected to the awareness issue. But I think the consumer behavior, is that if you do go on to the internet or social media and you buy a medicine, you recognize, okay, something's wrong, either the packaging or you took it and nothing happened, or whatever the case may be, I think there's a reluctance to report that because you're almost embarrassed that you were scammed.

They just may not know where to report it. I think that's the key messaging that goes on is creating the awareness, how do I report it, and really encouraging people to report. It's interesting, too. When you look at like the PSI data, you see that in the US, surprisingly (this data is public on their website), if you look regionally, the United States has the most incidents, and people say, how is that the case? How was it not China? Well, it's because our customs regime, our defenses are better. People are more likely to report.

In the fourth part of his Pharma Commerce video interview, Sean O’Hearen, founder and principal consultant at 1st Line Partners, describes the prominence of underreporting falsified medicines. 

Cracking Down on Illegal Online Pharmacies

With approximately 95% of online pharmacies classified as illegal or unsafe, yet both patients and providers are increasingly using them—sometimes for cost or access reasons—what regulatory or verification mechanisms would you recommend to safely legitimize online medicine procurement?

The regulatory and verification mechanisms are in place, and I haven't studied, internationally, all the various regimes, but if we can just focus on the US, the verification system is managed through the National Association of Boards of Pharmacy (NABP). They have a digital verification system. There's an FDA component to that. Of course, all the state-level licensing of pharmacies, all of that kind of system applies. The system is there, and it works. But the problem is, if you're a motivated offender, a bad actor, it's too easy to put a website up, go through social media channels. In regard to the discussion of online channels as the bane of our existence in this effort, everyone is aware of this, but it's a significant challenge.

The barriers to entry are very low. These product integrity programs, they spend a lot of their resources in the detection monitoring, takedowns, enforcement efforts—it's a constant battle. It's not surprising that you get this 95% number. I just looked at their website today, and there's 35 to 40,000 of these illegal online pharmacies that you can find at any one time. Those aren't the only platforms where people are selling. That’s the issue. The verification mechanism exists. That’s why I highlighted the article too.

From a consumer perspective and from a patient perspective, it's important to know how to verify. You can go to the NABP site, the Safe.pharmacy site, and take a URL and just put the URL in there and it will verify that against LegitScript. There are easy ways to verify, but again, it's the awareness issue. People are not aware. Convenience, access, and cost are the reasons why people will go to buy online. People in certain parts of the world, I think, certainly are fearful of getting substandard, falsified, counterfeit medicines. But I think in the US in particular, I think the mindset is more that they would be shocked that somebody would do that, that somebody would actually counterfeit a medicine.

In the third part of his Pharma Commerce video interview, Sean O’Hearen, founder and principal consultant at 1st Line Partners, recommends regulatory or verification mechanisms that can help safely legitimize online medicine procurement.

Creating a Unified Strategy to Advance Education on Counterfeit Medicines

Initiatives like BESAFE, the FIP & WHO Pharmacy Curriculum Guide on Substandard and Falsified Medicines, and the Partnership for Safe Medicines are cited as critical, yet underfunded. How should the private sector, including pharma manufacturers, strategically support and scale these efforts to ensure that HCPs globally receive standardized training?

I think they're already doing a lot, number one, but there are so many different organizations that are working this problem. I's not only the manufacturers. You have the associations like the Pharmaceutical Security Institute (PSI) that the manufacturers are a part of. A lot of other nonprofit organizations, trade organizations, of course, regulatory authorities. You have the World Health Organization and so on. There are so many different organizations, including all of the law enforcement community.

I think there is an opportunity for an alliance of alliances-type of concept. With all these different organizations that are trying to work this problem, getting aligned on a few sort of strategic pillars, education being one of them, that we can pursue in a more harmonized way. There's a lot to consider if you're trying to get do something like that. In my experience, and especially with the bigger pharmaceutical manufacturers that I've had experience with, they all have it as part of their strategy; it’s one of their strategic pillars. They all have an element that's devoted to advocacy and awareness, and engaging with external stakeholders, the whole variety of stakeholders. They have a budget that is connected with that, and then they need to decide, how are we going to allocate these resources? Are we going to focus on policy levers, on education levers, on training of law enforcement, public awareness? What is it? What are we going to do, in addition to what it costs to be part of some of these associations, which is not inexpensive. That’s where there's not alignment.

These different organizations where I think they're applying a lot of resources externally and sometimes in a coordinated fashion, like with a PSI or an Rx-360, but I think there's an opportunity to pull more resources to focus at an even higher level, on some of these initiatives. I would put this education piece of healthcare professionals in that category, if it were me deciding on the priority.

In the second part of his Pharma Commerce video interview, Sean O’Hearen, founder and principal consultant at 1st Line Partners, explains how the private sector should strategically support and scale efforts to ensure that HCPs globally receive substandard and falsified medicine detection training. 

Why Medical Education Must Catch Up 

Your article highlights that only 2% of HCPs are trained to identify substandard and falsified (SF) medicines, and over 80% don’t view SF drugs as a serious issue. What systemic gaps in medical and pharmacy education need to be addressed, and how can academic and clinical institutions accelerate awareness training?

Clearly, as the Johns Hopkins research indicates, it's a significant issue. The first thing I would say is that I think the industry is very pleased that the school with the resources of Johns Hopkins and their public health team recognize excellence, and the public health arena are getting behind this issue, and it's only been a couple of years. The report that I was referring to in the article was their second symposium, so they're just recently getting behind it, with sponsorship from Pfizer. Great to see that push.

One thing I should say is that I'm not an expert on medical and pharmacy education, number one. You can access that report through the BESAFE references, but that report you'll give some very specific recommendations, as far as what can be done to address the education gap that that they're seeing.

They're talking about all levels of education. It’s starting with undergrad curricula for healthcare professionals, pharmacists, folks who are interested in medical degrees. Of course, medical school having dedicated curricula around that, and continuing education related to that. I think there's also a component that pharmaceutical manufacturers and industry associations are doing today, and that is providing education to healthcare professionals, either in cases where they're reacting to an incident and a known issue, and then that education of those frontline workers becomes part of the solution.

I've been involved in many cases where we're trying to solve, and that's a significant part of the solution is educating those healthcare practitioners. Just as an example that's been at infusion centers: one of the trends we’re seeing is life-saving type of treatments—like oncology treatments—in certain parts of the world where counterfeits are turning up. It's enabling those nurses, who are working with the products and patients to help them understand how to identify counterfeit medicine.

The issue that the report highlights is that there are few standardized curricula. There's the International Pharmaceutical Federation, which, I think, at least based on what I've seen—I haven't done extensive research on this—but that's kind of the first of its type of a really, thoroughly researched and an organized effort. Notably, that was sponsored and put together by with the help of the World Health Organization and International Pharmaceutical Federation. The universities involved were in Africa. There were five countries in Africa, Nigeria, Uganda, Tanzania, and some others, so obviously, they're trying. The World Health Organization in particular is trying to focus on those parts of the world where this issue is even more significant than it is in other parts of the world. In terms of the big picture, I think we're in early stages on addressing the issue. Johns Hopkins isn't the only university that's getting behind this issue, but as more and more universities recognize it, I think that the goal would be to try to get this education into standardized curriculum.

In the first part of his Pharma Commerce video interview, Sean O’Hearen, founder and principal consultant at 1st Line Partners, lays out the systemic gaps in medical and pharmacy education that need to be addressed, along with how academic and clinical institutions can accelerate awareness training in identifying substandard and falsified medicines.

Peer Exchange: Understanding the Pharma Supply Chain (Episode 1)

This system plays a vital role in supporting both individual and public health. It ensures patient safety by maintaining drug quality, authenticity, and regulatory compliance. Additionally, it supports public health by providing consistent access to essential medications and vaccines. During times of crisis—such as pandemics, natural disasters, or supply disruptions—the supply chain becomes even more critical for delivering life-saving therapies and maintaining stability. Efficient supply chain logistics also contribute to cost control

In the first part of this roundtable discussion, a panel of subject matter experts introduce themselves, while discussing the strategies that are most effective in ensuring resilience across the global supply chain.

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