Founder and Principal Consultant at 1st Line Partners.

Sean O’Hearen, 1st Line Partners

Lack of Awareness Among Healthcare Providers. 

Despite being the first line of defense, most HCPs receive little to no training on identifying counterfeit or substandard medicines, which puts patient safety at risk.

Online Pharmacies Pose Significant Dangers. 

While more consumers and even HCPs are turning to online pharmacies for convenience or cost reasons, about 95% of these sites are illegal or unsafe, contributing to the spread of counterfeit medicines.

 Industry efforts such as the BESAFE project and global pharmacy curriculum initiatives are essential to increase awareness, improve training, and ensure safer medication practices across healthcare systems.

A global security leader I know often talks about the importance of raising awareness, not alarm, regarding the threat and risk of counterfeit and illicit medicines. The last thing you would want, he says, is to have someone fear taking their medication because they read, for example, a commonly cited statistic such as, “World police agency Interpol says more than one million people die each year from counterfeit drugs…”

Certainly, we don’t want to stoke fear, but the awareness aspect is critical, even though the risk may be low, generally speaking. It’s important as a consumer and vital as a healthcare provider (HCP) to know the basic telltale signs of a fake, along with the simple precautions people can take to ensure they are getting genuine, safe, and effective medicine. It can truly mean life or death.

Flipping the security leader’s point around, what we should be raising the alarm about, as an industry, is the serious lack of awareness on this issue, especially among HCPs, and specifically when it comes to purchasing drugs online. HCPs—doctors, nurses, and pharmacists—are a critical first line of defense in our fight against counterfeit medicines. In numerous counterfeit investigations that I’ve had experience with, an HCP has been the one who recognized that something was “off” with a product and reported it through quality complaint channels, which led to appropriate actions being taken.

HCPs are also in a position to advise patients of appropriate precautions to take when acquiring their medicines.

I first got the sense that awareness among HCPs was not what it should be when, a few years back, I met the head of professional education for all nurses of a major European healthcare system. She told me that nurses there received no formal education or training on the topic of counterfeit and illicit drugs. Then, recently, I read a report from the Johns Hopkins Bloomberg School of Public Health

 that highlighted the knowledge gap that exists among HCPs in the US regarding this issue. The data point that caught my attention was that “Only 2% of HCPs are trained to identify substandard and falsified (SF) [i.e., counterfeit] drugs and counsel patients about safe prescription acquisition procedures.” The report also cited a survey that indicated that “more than 80% of US HCPs do not consider SF drugs a serious concern.”

Raising the alarm even higher is the fact that more consumers are buying medicines online, a market shift that occurred during COVID-19 and has continued to persist and grow.

 We know this practice can be very risky due to the proliferation of counterfeit and illicit drugs online and the easy access that the internet affords. Since 2017, the Alliance for Safe Online Pharmacies has been reporting that roughly 95% of online pharmacies are illegal or unsafe.

Yet, there is a growing perception that buying medicines online is safe. It’s no longer just patients turning to the internet in desperation. Increasingly, I’ve read reports and heard anecdotally that HCPs themselves are recommending online pharmacies, especially Canadian ones, to help patients sidestep high drug costs or supply chain disruptions. While well-intentioned, this normalization of online drug buying, especially outside of regulated channels, poses serious dangers for patient safety and public health.

To the average person, many of these sites appear to be legitimate—complete with sleek design, fake seals of approval, and customer reviews. It seems we have some serious work to do to ensure that people understand how to purchase medicines online from safe and reputable sources—the Alliance for Safe Online Pharmacies offers resources to assist with that under their “Find Safe Online Pharmacies” section.

The good news is that major initiatives and alliances, such as the BESAFE project at Johns Hopkins, which is sponsored by Pfizer; the FIP & WHO Pharmacy Curriculum Guide on Substandard and Falsified Medicines; and the Partnership for Safe Medicines, to name a few, are focused on raising awareness; improving education and training among HCPs; and promoting advocacy on this important issue. As an industry, we need more support and funding for initiatives like these to help safeguard patients and consumers and preserve public trust in our healthcare system. 

Sean O’Hearen is Founder and Principal Consultant at 1st Line Partners.

1. Southwick, N. Counterfeit Drugs Kill 1 Mn People Annually: Interpol. Insight Crime. October 24, 2013. 

https://insightcrime.org/news/brief/counterfeit-drugs-kill-1-million-annually-interpol/

2. 2024 Symposium on Public Health Strategies to Combat Substandard and Falsified Drugs. Johns Hopkins Bloomberg School of Public Health. 2024. 

https://fakemedicinenomore.org/2024-besafe-symposium/

3. ASOP Global Releases Survey Noting Consumers Are Increasingly Purchasing Medications Through Online Pharmacies. National Association of Boards of Pharmacy. February 5, 2024. 

https://nabp.pharmacy/news/blog/regulatory_news/asop-survey-purchasing-online-pharmacies/

4. Alliance for Safe Online Pharmacies homepage. Alliance for Safe Online Pharmacies. 

5. Alliance for Safe Online Pharmacies’ “Find Safe Online Pharmacies” tab. Alliance for Safe Online Pharmacies 

https://buysaferx.pharmacy/find-safe-online-pharmacies/

Articles

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

Raising the Alarm

One of the objections I sometimes hear when discussing counterfeiting and diversion challenges with pharmaceutical manufacturers, particularly smaller ones, is that they just don’t know enough about the problem. They may suspect they have a problem and/or they may have seen some evidence of a problem, but they feel they lack sufficient data or knowledge to take concrete steps to address it—beyond doing the minimum required by law, of course, such as serialization. This knowledge gap may also lead them to conclude that even if a problem exists, the risk is likely to be low, and additional investment in product integrity is not warranted.

My response to this challenge is always that you probably know more than you think—you just need to know where to look. And, as for the risk, it may be greater than you perceive it to be—for your patients, your reputation, and your business. My best advice is to take proactive steps to gather the available data, which will enable you to better understand the issue and make an informed decision about what illicit trade risk management should entail for your business.

How do you know more than you think? Because your existing internal data and business intelligence, when viewed through a product integrity lens, can provide a trove of relevant and useful information. Digging into this data can begin to shed light on the issue and provide actionable insights. Your colleagues working in the commercial, quality, and supply chain areas may also be able to provide valuable information to help you begin to formulate a clearer picture of the risk. Consider the data sources in the below table and what they can tell you about illicit trade risk (click to enlarge). 

Knowing where to look and what the data can potentially reveal is, of course, just the first step on your data-driven journey to becoming better informed about illicit trade risk. Armed with a list of the relevant data sets and the questions you’re trying to answer with the data, that’s when you invite your data and analytics team to the table. They’ll need to understand the problem you’re trying to solve, then prepare the data and apply the appropriate analytical tools and techniques, such as machine learning, natural language processing, statistical analysis, and AI techniques, to obtain answers and actionable insights that will inform your decision-making.

The global threat of illicit trade continues to grow every year. If you wait to take additional preventive measures until a counterfeit product turns up online or in your legitimate supply chain, then it’s probably too late. It’s a lot more challenging to be in a reactive mode, trying to address patient safety and customer concerns, versus taking proactive steps now to conduct a rigorous assessment, followed by an informed leadership decision about what level of risk is acceptable and implementing a program that meets your objectives. It’s a risk you can’t afford to ignore.

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

Illicit trade activity (ITA) in the pharmaceutical industry has been on a steady rise globally since the Pharmaceutical Security Institute (PSI) began reporting annual incident statistics more than 22 years ago. According to PSI data, in 2023, pharmaceutical crime hit an all-time high, with 6,897 incidents reported.

 Over the five years of 2019-2023, incidents climbed about 8% yearly. These incidents cut across every therapeutic category and every region of the world. Risks related to ITA include activities such as counterfeiting, diversion, tampering, theft, and trademark infringement. As the problem grows, both the pharma industry and the public sector continue to direct more attention and resources toward dealing with this challenge and protecting patients, along with the integrity of our drug supply chains.

is introducing this new column to address issues related to ITA and to promote a dialogue regarding what we, collectively as an industry and through collaboration with the public sector, can do to combat the problem and protect patients and product integrity.

Unsurprisingly, criminals and bad actors involved in ITA prioritize profits over patient safety and health. They operate in the shadows, clandestinely, seeking to avoid detection, exposure, and accountability for their crimes. They comprise the “dark side” of pharmaceutical commerce, which we will aim to shed light on, stimulate discussion about, and help readers understand best practices, both proactive and reactive, for managing and controlling ITA risk.

It's important to understand that ITA risk, to varying degrees, touches virtually every phase of pharmaceutical product development, manufacturing, and distribution—from “make to take”—and every segment of a product’s lifecycle—from “launch to legacy.” Bad actors spot market opportunities and exploit vulnerabilities throughout the system with alacrity, ingenuity, and sophistication, not to mention greater agility than those of us who play by the rules. Their fraudulent schemes and methods are innumerable and dynamic, and it’s difficult for the good guys, the protectors, to prevail.

To effectively oppose the dark side, we have to think differently than we do when thinking about our legitimate business activities. We have to view our manufacturing and distribution system holistically and through a “product integrity lens,” meaning we have to ask ourselves: how can bad actors exploit and/or circumvent the regulated delivery system to achieve their nefarious aims?

Thus, the objective of this column will be to broaden the aperture of our product integrity lens and look at this problem and solution set from various angles, through case studies and exploration of current events, hot topics, and themes raised by the 

On that note, this issue covers topics such as retail pharmacy closures, pharmacy deserts, and third-party logistics (3PLs). To emphasize my point, all three topics have significant product integrity concerns related to them, which we don’t have the column space to get into now. However, I’ll briefly highlight some of the issues as an example of more to come in this space.

A key knock-on effect of pharmacy closures and subsequent pharmacy deserts is that people turn to the internet for their medicines. From a product integrity perspective, this is generally a bad idea. As the Alliance for Safe Online Pharmacies states on its home page,

 “At any given time, there are around 35,000 active online pharmacy websites—about 95% of which do not comply with applicable laws and pharmacy standards.” Online pharmacies are rife with illicit products, and manufacturers must invest significant resources in online monitoring and enforcement.

In terms of third-party logistics, this is an area that can keep pharmaceutical security leaders up at night. 3PLs are a key area of focus of product integrity programs, mainly due to cargo theft risk, especially in certain parts of the world, such as Brazil, Mexico, and South Africa. Proper vetting, auditing, and oversight of 3PLs is critical, as well as having processes and procedures in place for route planning, incident response, and regulatory compliance, to name a few.

I’m excited to have this forum and opportunity to raise awareness and understanding of product integrity challenges, which should concern everyone in this industry, not just those responsible for mitigating and managing ITA risk. I look forward to engaging with the 

 community going forward, and appreciate any feedback, questions, or suggestions readers have for future topics.

1. Latest publicly available PSI data at 

2. Alliance for Safe Online Pharmacies home page. 

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