Many patients and consumers have a mental picture of the last leg of the pharmaceutical supply chain as a neighborhood drug store where they pick up their prescriptions. The advent of the Internet age, however, renders that picture incomplete at best. Today, the Internet is an integral and routine part of the global medicines supply chain, often including the last leg of the chain, making at-home deliveries possible. The Internet’s role comes with both potential benefits and risks to global health, panelists suggested during an April 26 session of the Asia-Pacific Economic Cooperation (APEC) forum’s Medical Product Supply Chain Dialogue, co-hosted by the U.S. FDA and USP in Rockville, Maryland. The panel was titled “Securing the Downstream Supply Chain: Internet Pharmacies.”
To set the stage, it’s clear that benefits of the Internet’s role can include convenience, rapid access to medical information, privacy, cost efficacy and transparency, at-home access, and the wide range of medicines available. The risks, however, are numerous. Of the roughly 35,000 online pharmacies worldwide, 95% operate illegally across the globe – in violation of local laws and relevant pharmacy practice standards – and approximately 20 new illegal online pharmacy websites go live globally every day, according to statistics from the Alliance for Safe Online Pharmacies (ASOP). Organizations such as the World Health Organization have recognized the risks to patients of substandard and falsified products potentially being sold or distributed through these types of unregulated websites.
Many of these online marketplaces operate without a pharmacy license and sell medicines without requiring a prescription. This alone can present serious risks to patients’ health and public health. In addition, the potentially substandard, unregistered/unlicensed, and falsified medicines they may be supplying can have:
- Unverified information, such as information on content or claims;
- Harmful ingredients or controlled substances that may cause harm;
- An unexpected interaction with other medicines, cause dangerous side effects, or may cause other serious health problems, such as severe allergic reactions; and
- Serious public health consequences, including contributing to antimicrobial resistance and drug-resistant infections.
Members of the APEC panel on the topic discussed illegal online pharmacies as a “whole of Internet problem” with nearly overwhelming size and scale.
Patients do not understand the risks of online pharmacies
Anyone who makes a purchase from an illegal online pharmacy can potentially be at risk, emphasized panelist Libby Baney, a partner at international law firm Faegre Drinker and a senior advisor to ASOP. “It’s not just an abstract idea, it’s our sisters, it’s our children, it’s our parents who are being duped by Internet criminals taking advantage of demand, fear, and public health need,” Baney suggested.
A recent ASOP survey found that 42% of Americans have purchased medications online, largely due to perceived benefits of convenience and cost, and 45% of Americans erroneously believe all websites offering healthcare services/prescription medications to Americans have been approved by the FDA or state regulators. Furthermore, 38% of Americans have been exposed to an event where someone received a substandard or counterfeit prescription medication from an online source, according to the ASOP survey. The challenges associated with online pharmacies are not just limited to the distribution of counterfeit medicines – they also include the potential to exacerbate addiction and substance abuse through the availability of controlled substances.
A need exists to provide consumers, providers, policymakers, and other stakeholders information about how to stay safe when shopping for medicines both online and offline. To that end, the ASOP Global Foundation, the National Association of Boards of Pharmacy, and the Los Angeles County Sheriff’s Department recently partnered to raise patient and provider awareness about the public health crisis of counterfeit medicines and the dangers of buying from illicit and online sources. A related public service announcement, titled “Bad meds kill real people,” includes a video featuring film star and restaurateur Danny Trejo, and tips to avoid purchasing fake medicines online.
Research can support best practices for stakeholders
Research is critical to develop credible data, understand trends, and gather information about counterfeit medicines and illicit online drug sellers, suggested panelist Tim Mackey, a professor in the Global Health Program and director of the Global Health and Data Policy Institute at the University of California, San Diego. He provided details about research his team has recently undertaken that illustrates some of the challenges faced in the online pharmacy space. The results are unsurprising – numerous drugs are available on the Internet and can be purchased easily. For example, his group analyzed antibiotics purchased online and the potential safety risks specific to that treatment category. They include the potential for substandard packaging and shipment, falsification of product information and markings, detection of undeclared chemicals, high variability of quality across samples, and payment for orders being subject to fraud. Mackey’s team is working to understand drug purchasing behavior online to help inform patient education initiatives, and to evaluate the technology features of illegal online sales to help distinguish legitimate online pharmacies from others.
Research also can support evidence-based policy making, and proactive prevention measures to promote a safe and robust supply chain. The utilization of innovative detection technologies such as big data surveillance, machine learning, and forensic analysis can – and should – be leveraged to help with investigations of counterfeit or substandard medicines purchased online, Mackey suggested. This evidence can help support best practices for industry, regulators, and practitioners on risk identification, consumer purchasing behavior, education, and identifying risk between platforms.
Collaboration is necessary to protect the public
“Communication, collaboration, and compliance are some of the key cornerstones to protecting patients,” opined panelist Sangeeta Chatterjee, Pharm.D., deputy director of FDA’s Office of Drug Security, Integrity and Response (ODSIR) at the agency’s Center for Drug Evaluation and Research. FDA is committed to working alongside U.S. and international partners to raise awareness about the risks associated with online pharmacies and improve patient safety.
Some of the ways FDA is addressing the illegal sale of unapproved and misbranded drugs online include collaboration with both public and private partners, issuing warning letters to entities in violation of the law, holding summits to encourage open and candid discussion of problems and solutions associated with online sales of controlled substances, initiating criminal investigations, and education and outreach campaigns. The goal is proactive and effective work across public and private stakeholders – including national regulatory authorities, law enforcement, customs officials, non-governmental organizations, manufacturers, distributors, Internet commerce companies, and more – to bring about meaningful actions that make the Internet safer for patients and consumers worldwide.
What can we do?
Trends driving illegal online sales of medical products show no signs of slowing, with an even bigger global market likely in the future.
Recognizing the challenges of securing what has now become a very complex and global supply chain, APEC commissioned a group of international stakeholders to develop a resource called the Supply Chain Security Toolkit for Medical Products. The collaborative, multi-year project was led by regulators and representatives from industry, academia, non-governmental organizations, and international groups. The resource is intended for use by regulatory agencies and law enforcement in APEC and non-APEC economies to help secure all aspects of the pharmaceutical supply chain – from raw materials to products used by patients. This includes helping to prevent and detect substandard and falsified medical products before they reach patients, and effectively respond to incidents involving such products. One component of the toolkit specifically addresses best practices for combatting illegal online medical product sales.
Other resources are also available. For example, organizations such as the Pharmaceutical Security Institute (PSI) are working in the Asia-Pacific region to share information on the counterfeiting of pharmaceuticals and initiating enforcement actions. USP continues to work with ASOP, FDA, the Fight the Fakes Alliance, and others to secure the global supply chain to prevent substandard and fake medicines from reaching patients. Such USP efforts in recent years have included addressing the potential for substandard and falsified COVID-19 vaccines, particularly in low- and middle-income countries. To learn more and to find safe online pharmacies, visit the ASOP website.