The Global Fight Against Illegal Online Pharmacies and Counterfeit Medicines
Libby Baney, JD
Principal, Faegre Baker Daniels Consulting and Counsel, Faegre Baker Daniels
Alliance for Safe Online Pharmacies (ASOP Global)
According to the World Health Organization, it is estimated that up to a third of the world’s prescription drugs are counterfeit, although this figure is closer to two-thirds in some developing countries. Worth $200 billion a year, the market for counterfeit pharmaceuticals now eclipses almost everything in the underground economy, including prostitution, human trafficking and illegal arms sales.
In October, police, customs and health regulatory authorities from 123 countries, including the United States, Canada and Europe, participated in INTERPOL’s Operation Pangea X, leading to the seizure of 25 million illicit and counterfeit medicines worldwide worth more than $51 million, 400 arrests, removal of 3,584 illegal online pharmacy websites, and suspension of more than 3,000 illegal online advertisements for illicit drugs.
While the results of this international effort were impactful, at any given time there still are more than 30,000 illegal online drug sellers offering medications without a physician’s prescription, including opioids and other controlled substances; selling counterfeit or falsified medicines; and/or operating without a pharmacy license in the country in which the patient is located. These illegal acts put patients at risk.
Some “medications” sold online look genuine but can contain too much, too little or no active ingredients, other pharmaceutical products, and/or poisons such as paint thinner, antifreeze and floor wax. Others are not properly handled or stored before reaching customers, diminishing their efficacy or rendering them unsafe for consumption.
In addition, rogue pharmacy websites exploit a global postal system that, in many instances, lacks sufficient screening protocol for shipments. In the U.S., the Synthetics Trafficking and Overdose Prevention (STOP) Act of 2017 has been introduced in the House of Representatives and Senate to help close this loophole. Efforts are underway to ensure passage of this legislation, most recently through recommendations included in the final report prepared by the President’s Commission on Combating Drug Addiction and the Opioid Crisis.
THE ALLIANCE FOR SAFE ONLINE PHARMACIES (ASOP Global)
The Alliance for Safe Online Pharmacies (ASOP Global), founded in 2009, is singularly focused on and united in its mission to combat illegal online pharmacies and counterfeit medicines in the United States, Europe, India, and Asia through research, education and advocacy.
In 2017, we announced the establishment of the ASOP Global Foundation, a charitable, not-for-profit organization dedicated to addressing the growing public health threat of illegal online drug sellers, concentrating the Foundation’s activities in research and education to inform consumers and policymakers.
The Alliance for Safe Online Pharmacy (ASOP EU) was established in 2011 to create an environment that enables patients to buy their medicines online safely in European countries where it is legal for them to do so. We also recently established ASOP Canada to engage Canadian stakeholders.
Members of ASOP Global, ASOP EU and ASOP Canada include healthcare providers, patient safety groups, public health and non-profit organizations, pharmaceutical manufacturers, government entities and Internet commerce stakeholders that share our commitment to making the Internet safe for consumers worldwide.
ASOP Global’s research into the operations of rogue pharmacy websites and the danger they present to the public is key to changing consumer perceptions and the public- and private-sector policy response.
ASOP Global and the Foundation have published numerous reports and studies in the U.S., Europe and Asia, addressing different aspects of this issue, and what has been done – and must still be done – to combat rogue online drug sellers.
Research conducted on the sale of prescription opioids online and healthcare provider awareness and identification of illegal sites and has helped to shine a light on this public health threat, as well.
In November 2017, for example, results from a new peer-reviewed study published in the American Journal of Public Health (AJPH), “Machine Learning to Detect Prescription Opioid Abuse Promotion and Access via Twitter,” found online pharmacies are using Twitter to illegally market and sell Percocet®, Vicodin®, Oxycontin®, hydrocodone, fentanyl and oxycodone and other highly addictive and often deadly controlled substances to U.S. consumers, in direct violation of U.S. federal law.
ASOP EU and the European Alliance for Access to Safe Medicines also published results from its “Fighting Fakes by Raising Public Awareness” campaign, which was created to prove that patients and caregivers could be engaged to enter into an informative educational website to learn more about falsified medicines and the dangers therein, whether or not they were previously aware of the dangers of such sites.
Educating consumers is one of ASOP Global’s top priorities around the globe. At the beginning of 2017, we launched our new website, www.buysaferx.pharmacy, to provide our members, patients and caregivers, healthcare providers, law enforcement officials, government entities and the media with the most up to date information and resources, as well as tools to safely buy prescription medicines online.
We also have conducted several major public awareness campaigns. BuySafeRx, our first general consumer campaign, was intended to educate U.S. consumers about potentially life-threatening health and financial risks associated with buying prescription medicines online.
In addition to conducting a traditional media relations campaign, we also co-authored a blog with Carmen A. Catizone, MS, RPh, DPh, executive director of the National Association of Boards of Pharmacy® (NABP®), “Battling the Epidemic of Illegal Online Drug Sellers and Counterfeit Medicines,”, which was published by the U.S. Pharmacopeial Convention (USP), and participated in a nationally syndicated podcast on eHealthRadio.
Understanding the increased number of prescription medications that older Americans rely on – and the out of pocket costs they are faced with – is imperative to provide them with the tools they need to stay safe when shopping online.
ASOP Global joined forces with the Center for Safe Internet Pharmacies (CSIP) and National Consumers League (NCL) to conduct the first Older Americans campaign to educate this vulnerable population, and their caregivers, about the health and financial risks associated with buying prescription medicines from illegal online pharmacies.
ASOP Global and the Federation of State Medical Boards also worked with the U.S. Food and Drug Administration (FDA), University of California San Diego and LegitScript to develop “Internet Drug Sellers: What Providers Need to Know”, a free online continuing education program for pharmacists and physicians that engaged over 1,000 healthcare providers during the two-year program.
Based on the results of the CME/CPE programs, we partnered with sixteen non-profit organizations, including the American Medical Association and American Pharmacists Association, and launched our first Healthcare Providers Campaign to educate the 6 million healthcare providers in the U.S. about the proliferation of illegal online pharmacies and counterfeit medicines and provide them with a Healthcare Providers Toolkit to help them keep their patients safe online.
In 2017, ASOP Global engaged in a three-month campaign on Canadian online pharmacies and drug importation to educate consumers and members of Congress about the risks associated with buying prescription medicines from online pharmacies marketing themselves as “Canadian” and how the legalization of importation of prescription drugs from Canada and other foreign countries would endanger consumers by threatening the protections provided by the Drug Supply Chain Security Act of 2013.
As part of this effort, ASOP Global worked with partners from the Purdue University College of Pharmacy to publish a white paper on the results from the most comprehensive survey ever conducted to evaluate consumer behavior and perceptions about online pharmacies.
ASOP sponsors and/or participates in international forums, workshops and events to further our mission. Here are some highlights from 2017:
ASOP Global and The Pew Charitable Trusts cosponsored “The Security of the Drug Supply Chain, Patient Safety and Drug Importation” in Washington, DC. We were joined by representatives from LegitScript, Purdue University College of Pharmacy’s Center for Medication Safety Advancement (CSMA), and an online pharmacy victim to discuss the worldwide proliferation of illegal online pharmacies; protections provided by the Drug Supply Chain Security Act; risks associated with legalizing importation of prescription medicines from Canada and other countries; and consequences for patients who are exposed to unsafe products.
ASOP Global presented the inaugural Global Patient Safety Champion Awards to the Honorable Michael C. Burgess, MD (R-TX-26), Chairman, U.S. House Energy and Commerce Subcommittee on Health; the Honorable Eugene Green (D-TX-29), Ranking Member, U.S. House Energy and Commerce Subcommittee on Health; and the National Association of Boards of Pharmacy (NABP) in Washington, D.C.
ASOP Global’s inaugural Internet Pharmacy Safety E-Commerce Leadership Award was presented to Rightside and Realtime Register during the Generic Names Supporting Organization (GNSO) Joint Meeting of the Registries and Registrars Stakeholder Groups at ICANN58 in Copenhagen.
ASOP EU’s Executive Director Mike Isles and other international experts led the Global Health/Access to Safe Medicines Session during the 2017 European Association of Clinical Pharmacology and Therapeutics (EACPT) Congress, which was held in Prague.
ASOP Global and ASOP EU hosted the fifth Best Practice Sharing Workshop in Paris, where we were joined by 20 EU member states and not-for-profit organizations to discuss the need for more public awareness programs about falsified medicines in line with those previously conducted by ASOP Global in the U.S. and Europe; the “Common Logo”, which must appear on every online pharmacy selling medicine in Europe; and the latest progress relating to NABP’s .pharmacy top level domain (TLD) initiative.
ASOP EU was among the Fight the Fakes partners representing healthcare professionals, academia, non-governmental organizations (NGOs), the pharmaceutical industry, healthcare distributors, and consumer protection organizations that participated in the recent Fight the Fakes international meeting in Brussels where they discussed plans to raise awareness of and the dangers associated with the widespread sale and use of falsified medicines.
ASOP Global, NABP and the Canadian Pharmacists Association (CPhA) also hosted the Canadian Online Pharmacies Forum during the 2017 Canadian Pharmacists Conference where more than 700 pharmacists and pharmacy stakeholders discussed key issues facing Canada’s healthcare system, including the opioid crisis, mental healthcare and antimicrobial stewardship.
Representatives from ASOP Global and NABP also were speakers at the first Canadian Internet Drug Sales Roundtable, held during NABP’s 113th annual conference.
ASOP Global was joined by 160 representatives from the Government of India (Gol), Partnership for Safe Medicines (PSM) India Initiative, International Alliance of Patients’ Organizations (IAPO), Indian Pharmacopeia Commission (IPC), U.S. Pharmacopeial Convention (USP) and other international organizations for the first International Forum on Patient Safety and Access to Safe Online Pharmacies in New Delhi, India.
THE INTERNATIONAL OPIOID EPIDEMIC and ILLEGAL Online Pharmacies
Thousands of rogue pharmacy websites illegally sell consumers genuine and counterfeit fentanyl, Percocet®, Vicodin®, Oxycontin®, other controlled substances and sell criminals who seek to do people harm the pill presses with which to manufacture counterfeit pills.
Earlier this year, investigators found that AlphaBay, the leading dark-net market, had more than 21,000 listings for opioids and more than 4,100 for fentanyl and similar drugs.
For these and other myriad reasons, the growing international opioid epidemic will be a major priority for ASOP Global and our partners in the coming year. Here’s a snapshot of the opioid issue in the U.S., Europe and Canada.
The U.S. Centers for Disease Control (CDC) estimate that almost 144 people die every day from opioid-related overdoses, with this number expected to rise with the release of CDC’s 2016 morbidity and mortality results. Due to their potency, synthetic opioids, such as fentanyl and its molecular analogues have become the fastest growing cause of the overdose epidemic.
Unlike heroin and prescription painkillers, enough fentanyl to get nearly 50,000 people high can fit in a standard first-class envelope and an investment of a few thousand dollars can net these illegal actors millions of dollars in profits.
According to the European Monitoring Centre for Drugs and Drug Addiction, drug overdose deaths in Europe rose six percent in 2015, rising for the third consecutive year and driven by the increasing use of synthetic opioids like fentanyl. The European Commission’s Early Warning System (EWS) has been receiving an increasing number of reports of falsified or adulterated opioids since 2012. These substances are often mixed with heroin, fentanyl or other illicit drugs and counterfeit medications sold through online pharmacies and on the dark web.
As is true in the U.S. and Europe, Canadian residents are increasingly turning to the Internet or black market to obtain prescription pain medications when they can no longer legally obtain these drugs. Further, although fentanyl and its analogues are classified as controlled substances in Canada, making them illegal to import without a license or permit, online suppliers devise ways to conceal the drugs and avoid inspection rules. In 2016, the growing number of overdoses and deaths caused by opioids was declared a national public health crisis by the Government of Canada’s Minister of Health, resulting in the Joint Statement of Action to Address the Opioid Crisis.
Moving into 2018, ASOP Global, the ASOP Global Foundation, ASOP EU and ASOP Canada will continue to work tirelessly around the world to educate patients, healthcare providers, legislators, patient safety organizations, government entities and others about the threats associated with illegal online pharmacies and counterfeit medicines to ensure the safety of every consumer ac