In a video interview with Pharma Commerce, 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.
A transcript of his conversation with PC can be found below.
PC: 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?
O’Hearen: 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.