Illegal online sellers threaten the health, privacy, and security of patients by failing to comply with the laws of the jurisdiction in which they are located, or the jurisdiction in which they are selling their medicines.
The internet now plays a routine and significant role in the global pharmaceutical supply chain, explained Carrie Harney, vice president of US Government and Regulatory Affairs at US Pharmacopeia (USP) and chair of the Alliance for Safe Online Pharmacies, during the USP-FDA co-sponsored Asia-Pacific Economic Cooperation (APEC) Medical Product Supply Chain Dialogue at USP headquarters in Rockville, Maryland. Harney explained further that many patients now use internet pharmacies as a primary method of obtaining their medicines.
“This brings benefits but also risks when we think about buying medicines online,” Harney said. “When the internet pharmacy is lawful and part of the regulated supply chain, benefits may include convenience for patients, rapid access to medical information, privacy, cost efficiency and transparency, a wide range of medicine availability, and at-home access.”
However, Harney noted that the risks when patients use online pharmacies are numerous.
“According to the Alliance for Safe Online Pharmacies, 95% of online pharmacies operate illegally across the globe,” Harney said. “It is estimated that approximately 20 new illegal online pharmacies go live globally each day.”
The rise in illegal online sales of medical products can be attributed to several global trends, such as increased internet connectivity and usage overall, rising patient confidence in online shopping, the high cost of medical products, and increased demand for access to vaccines and treatments, according to Harney.
“And all of these factors became stronger during the COVID-19 pandemic. Moreover, we see time and time again that when demand for medication is high or access is constrained, patients turn to the internet, and too often bad actors respond to meet demand,” Harney said. “I think we've seen examples, especially during the COVID-19 pandemic when within minutes of that pandemic being declared, 100,000 websites were launched with names like ‘corona’ and ‘virus’ in the website name, and many of those were determined to be malicious websites.”
Illegal online sellers threaten the health, privacy, and security of patients by failing to comply with the laws of the jurisdiction in which they are located, or the jurisdiction in which they are selling their medicines, Harney explained. These pharmacies often operate without a license, and often without requiring a prescription. Beyond these concerns, it is not uncommon for illegal pharmacies to sell substandard, falsified, or counterfeit products that may contain little to no active ingredient or may be contaminated with other harmful ingredients.
“These sorts of medicines can put patients’ health at serious risk,” Harney said. “In addition to the negative implications for individual patients, there are also concerns for public health to take into account, including, for example, contributing to antimicrobial resistance. Looking ahead, unfortunately, it seems that the global market for these illegal online sellers will be even bigger.”
Harney explained further that the nature of illegal online sellers of pharmaceuticals continues to evolve as well.
“As a parent of teenagers, this is terrifying to me—consider that, in addition to traditional internet pharmacy websites, we have increased use of social media platforms to market and sell medical products illegally,” Harney said. “I think the challenge is that the scale and size of [this problem] can be overwhelming.”
However, Harney noted that the solutions to these online illegal pharmacies are also not being broadly discussed. Specifically, the APEC toolkit has been created to help combat illegal internet medical products sales, and this toolkit has been made available to aid in the control of this problem online.
“This toolkit is meant to serve as a resource for regulatory agencies, law enforcement, and other stakeholders in the APEC and non-APEC economies,” Harney said. “It includes best practices for combating illegal online medical product sales, and our hope is that this toolkit can be leveraged to make the internet a safer place for patients and consumers around the world.”
Harney C. Securing the downstream supply chain: internet pharmacies. Presented at: APEC Medical Product Supply Chain Dialogue in Rockville, Maryland; April 25, 2023.