Research Symposium

Spotlight On Illegal Online Sales Of Medicine 

November 14, 2018
National Press Club
529 14th St NW, Washington, DC

The growing threat of illegal online pharmacies coupled with the ongoing opioid crisis makes robust research and education more critical than ever for health professionals, law enforcement, and policymakers as they work to help patients stay safe online.

The Alliance for Safe Online Pharmacies (ASOP Global) Foundation’s 2018 Research Symposium will feature leading academic research presentations and thoughtful dialogue on timely topics including: patient safety and medication quality online, algorithm science, law enforcement best practices, and consumer behavior online. In addition to learning about these issues, attendees will participate in the development of new research agenda to inform the future efforts of ASOP Global Foundation and other stakeholders working to protect patients online.

Agenda

8:30 am

Registration

9 – 9:15 am

Welcoming Remarks

Libby Baney, Alliance for Safe Online Pharmacies Global Foundation

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Libby BaneyLibby Baney is a principal and counsel with Faegre Baker Daniels and currently serves as senior advisor to the Alliance for Safe Online Pharmacies Global (ASOP Global). Libby works to protect consumers online by focusing on issues at the intersection of Internet, technology and health, such as Internet pharmacies and pharmacy compliance, telemedicine, mobile health, and Internet governance.

As a nationally respected advocate for patient safety and public health, Libby works closely U.S. Congress, government agencies such as the Food and Drug Administration and State Department, law enforcement agencies and divisions, and internationally with organizations such as The European Commission and the Asia-Pacific Economic Cooperation.

Libby is a prolific speaker and writer, regularly authoring policy papers, leading strategic workshops with corporate leaders and advising policymakers. Her work has been profiled in The Washington Post, Politico, USA Today, Inside Health Policy, ABC News, CNN, CSPAN and other national media outlets.

9:15 – 10 am

Morning Keynote Presentation

Donald Ashley, Director, Office of Compliance, Food and Drug Administration

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Donald Ashley

As Director of CDER’s Office of Compliance, Donald D. Ashley, J.D., leads efforts to protect the American public from unsafe, ineffective and low-quality drug products through measures designed to assist industry-wide compliance with federal standards for quality and safety, as well as regulatory and enforcement measures to address violations of those same standards.

Mr. Ashley joined FDA after more than 18 years of criminal enforcement and investigation experience with the Department of Justice (DOJ). His many positions with DOJ included serving as a Trial Attorney in the Office of Consumer Litigation (now the Consumer Protection Branch), where he prosecuted consumer fraud offenses and violations of the Food Drug and Cosmetic Act (FD&C Act), and as Associate Director of the Office of International Affairs, where he managed international criminal law enforcement cooperation with countries throughout the world, represented DOJ’s interests within the United Nations, and negotiated law enforcement cooperation treaties.

Mr. Ashley received a bachelor’s degree in political science from John Carroll University in Ohio and earned a law degree from Harvard Law School.

10 – 11 am  

Session I: Scope and Significance of the Problem Online

Louise Shelley, Professor Schar School of Policy and Government, George Mason University

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Louise ShelleyDr. Louise Shelley is the Omer L. and Nancy Hirst Endowed Chair and a University Professor at Schar School of Policy and Government, George Mason University. She founded and directs the Terrorism, Transnational Crime and Corruption Center (TraCCC).

Her most recent books are:

  • Dark Commerce: How a New Illicit Economy is Threatening our Future (Princeton University Press, 2018) was written while an inaugural Andrew Carnegie fellow and addresses online illicit marketplaces for pharmaceuticals.
  • Human Trafficking: A Global Perspective (Cambridge 2010).

Her forthcoming book, Dark Commerce: How a New Illicit Economy is Threatening our Future (Princeton University Press, 2018) was written while an inaugural Andrew Carnegie fellow. She is the author of many articles and book chapters on transnational crime, Soviet and Russian crime and justice and money laundering.

Professor Shelley served for six years on Global Agenda Councils of the World Economic Forum first on the illicit trade council and then as the inaugural co-chair of organized crime.

Dr. Shelley appears frequently in the media, lectures widely at universities and multinational bodies and has testified repeatedly before Congress. She is a life member of the Council on Foreign Relations.

 

Presentation Takeaways

  1. Illicit pharmaceuticals have grown significantly with the new technology that affords anonymity and ease of payment
  2. Illicit online marketplaces often sell inferior drugs
  3. The web rather than the dark web is key to this trade

Marty Allain, Senior Program Manager, National Association of Boards of Pharmacy

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Marty AllainMarty Allain is the Senior Manager for NABP’s .Pharmacy Verified Websites Program, which is recognized as a 3rd party pharmacy merchant certifier by Visa and Mastercard. In addition, Google, Bing, Yahoo!, Twitter, and Snapchat recognize NABP pharmacy merchant certification for prescription medication advertising.

Marty is an attorney with over 20 years of regulatory and legislative experience. Marty previously served as General Counsel and Legislative Director for Indiana’s Professional Licensing Agency, Director of the Indiana Board of Pharmacy, and Director of Indiana’s prescription drug monitoring program (PDMP). In his prior role at NABP, Marty worked to streamline physician and pharmacist access to PDMP data through the integration of patient prescription records directly into electronic health record and pharmacy management systems.

 

Presentation Takeaways

  1. Discuss the availability of opioids online and the trends NABP is documenting
  2. Discuss the promotion of these websites via social media https://nabp.pharmacy/social-media-sites-the-new-wild-west-for-illegal-online-pharmacies/ 
  3. Discuss ways search and social media companies can mitigate some of these issues. In a September 2018 published report, the National Association of Boards of Pharmacy® (NABP®)documented the ready availability of rogue drugs sellers on social media platforms and easily discovered social media posts leading to rogue pharmacy websites selling commonly counterfeited and/or abused prescription medications; characteristics of these illegal sites include selling medicine that was not approved by the United States Food and Drug Administration, not requiring a prescription, and selling controlled substances.
  4. In a February 2018 published report, NABP evaluated 100 websites selling medications to patients in the US, and all of them were found to be operating illegally with:
    54% of the sites were selling controlled substances (CS). This is a substantial jump from the 13% of all sites NABP has reviewed and listed as “Not Recommended” in the past nine years that were selling CS.
    98% of the sites did not require a valid prescription.
    76% of the sites offered foreign or non-Food and Drug Administration-approved drugs.
    40% of the sites were selling CS, including opioids frequently linked to fentanyl-related overdoses. The most common CS being offered with no prescription was Xanax®, a drug whose counterfeit could contain fentanyl.

Resources

https://nabp.pharmacy/fraudulent-online-drug-sellers-making-opioid-epidemic-worse/
https://nabp.pharmacy/social-media-sites-the-new-wild-west-for-illegal-online-pharmacies/

Elizabeth Miller, VP U.S. Regulatory Affairs, United States Pharmacopeia

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Elizabeth MillerElizabeth Miller, Pharm.D., is Vice President, U.S. Public Policy & Regulatory Affairs, for USP. She leads USP’s strategic engagement and collaboration with the U.S. Food and Drug Administration (FDA) and other domestic regulatory agencies and stakeholders.

Dr. Miller returned to USP after nearly 10 years with the FDA Center for Drug Evaluation and Research (CDER)—where she most recently served as Director, Division of Nonprescription Drugs and Health Fraud, in the Office of Unapproved Drugs and Labeling Compliance. Prior to her FDA service, Dr. Miller spent nearly 10 years at USP, where her work focused on drug nomenclature, labeling, packaging, and patient safety standards to prevent medication errors and adverse events.

Dr. Miller’s extensive experience in health care and medicines-related work also includes several years as a clinical pharmacist at the Washington Hospital Center in Washington DC. Dr. Miller earned her Bachelor of Arts in Biology from The Johns Hopkins University, and her Doctor of Pharmacy from the University of Maryland, School of Pharmacy.

 

Presentation Takeaways

  1. In the context of online pharmacies, patients are at risk of adverse outcomes that radiate outward from product, practice, and regulatory challenges that stem from patient safety, drug quality, transparency, and security issues
  2. Effective interventions and disruption in the illegal online pharmacy business models are met with countermeasures; multiple prongs will require unique and evolving solutions to keep pace with the “economics” of the marketplace
  3. Public standards-based approaches to quality can help ensure product integrity and patient confidence and should be considered as part of a holistic systems approach

Themes to Explore

  • What is the scope of illegal online drug sales globally?
  • How do illegal online drug sales connects to the opioid epidemic
  • What is the role of internet companies and algorithms?
  • What do we know about the quality of medicines sold online, including through chemical analysis?

11 – 11:15 am

Coffee Break

11:15 – 12:15 pm

Session II:  Consumer Behavior and Patient Safety Considerations

John B. Hertig, Associate Professor, Butler University College of Pharmacy and Health Sciences and ASOP Global Board Member

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John HertigJohn B. Hertig, PharmD, MS, CPPS is an Associate Professor in the Butler University College of Pharmacy and Health Sciences.

He received his Bachelor of Science in Pharmaceutical Sciences and Doctor of Pharmacy degrees from Purdue University. He completed a PGY1 pharmacy practice and PGY2 health-system pharmacy administration residency at The Ohio State University Medical Center while also obtaining a Masters degree in Health-System Pharmacy Administration from The Ohio State University.

Dr. Hertig has lectured and published on a variety of leadership, administration, patient safety, and health policy topics, and is a member of the Editorial Advisory Board for The Joint Commission Journal on Quality and Patient Safety.

He holds various national and international appointments, including advisory roles with the US Food and Drug Administration and the Patient Safety Workgroup of the International Pharmaceutical Federation. Dr. Hertig is a member of the Board of Directors for the Alliance for Safe Online Pharmacies – Global, where he leads efforts to reduce the patient safety impact of illegal and counterfeit online drug distribution worldwide.

He has served as President of the Indiana Society of Health-System Pharmacists and is Immediate-Past Chair of the Legislative and Regulatory Council for the Indiana Pharmacist Alliance. Dr. Hertig received the Glen J. Sperandio award, honoring the Indiana Health-System Pharmacist of the year, the “Excellence in Innovation” Award, and the Medication Safety Pharmacist of the Year award in the State of Indiana.

 

Presentation Takeaways

  1. 55% of respondents have or would buy online, yet less than 5% know how to do so safely.
  2. Of all respondents, 91% do not discuss where they get their medicines with from a provider.
  3. Educated consumers take less risks; therefore, more education is needed for healthcare providers and consumers.

Sally Greenberg, Executive Director, National Consumers League

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Sally Greenberg:Sally Greenberg is the Executive Director of the National Consumers League. Sally has testified numerous times before Congress on consumer protection issues, including on product safety, fraud, excessive fees on car rentals, consumer rip-offs in calling cards and in support of protections for farmworker children.

Sally came to NCL from Consumers Union, where she worked from 1997-2007 on product liability and food safety issues, along with auto and product safety. Previously, Sally worked at the U.S. Department of Justice Foreign Claims Settlement Commission and prior to that, she spent a decade serving as the Eastern States Civil Rights Counsel for the Anti-Defamation League, based in Boston. Sally was president of the Women’s Bar Association of Massachusetts and the Women’s Bar Foundation, and served on several gubernatorial commissions in Massachusetts.

Sally served for many years on the board of directors of the Alliance for Justice, and HALT, an organization whose mission is the protection of the rights of consumers in their interactions with lawyers and the legal system. Sally is a member of the Reagan-Udall Foundation Board, a nonprofit established by Congress to support the mission of the FDA and help equip the agency with the highest caliber regulatory science and technology. She also serves on the board of the Keystone Center, which helps leaders in health, energy, environment and education battle contentious issues with a consensus-based approach. Sally also served for over a decade on the board of directors of Trillium Asset Management, the oldest and largest investment management firm dedicated to socially responsible investing.

Presentation Takeaways

  1. Medications for erectile dysfunction (ED) are among the most commonly sold medications on the gray market. In fact, 16% of men (2.4 million) age 18+ who treat ED with medication purchase it through a gray market channel, according to a survey conducted by Ipsos.
  2. The same factors that make many men reluctant to seek medical care for ED correlate with their motivation to purchase ED medications through the gray market.
    • The Ipsos survey found the top reasons for purchasing ED medications through the gray market include convenience; preservation of privacy or avoidance of embarrassment; the absence of or limited insurance coverage; and the availability of preferred strength or dosage.
  3. Medicines procured on the gray market infrequently come with prescription information or directions for use, which may put men at higher risk of adverse events.
    • The Ipsos survey revealed that 25% or fewer purchasers were asked to provide medical history, specifically as it relates to heart health, before purchasing ED medications. Furthermore, 55% of gray market purchasers were not provided with or do not recall receiving any information regarding the possibility that their ED may indicate an underlying cardiovascular condition.
  4. Reclassifying ED medications as over-the-counter (OTC) drugs has the potential to enhance consumer safety by reducing reliance on illegal online pharmacies and other gray market channels.
    • The Ipsos survey found that 70% of gray market purchasers said they would definitely buy ED medicines if available as an OTC product, further supporting the impact the switch in designation could have on deterring use of the gray market.

Themes to Explore

  • What do consumers think about buying medicine online?
  • What do health professionals know about online sales of medicine?
  • Does growing internet use relate to rise in drug abuse?
  • What are the most urgent needs to fill education gaps?

12:15 – 1:15 pm

Lunch Keynote Presentation

Michael Kopcha, Director, Office of Pharmaceutical Quality, Food and Drug Administration

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Michael Kopcha

Michael Kopcha, Ph.D., R.Ph. is the Director of the FDA’s Office of Pharmaceutical Quality (OPQ). This office has over 1,300 staff responsible for assuring the availability of quality medicines for the American public through assessment, inspection, surveillance, research, and policy. OPQ contributes to the assessment of nearly every type of human drug marketing application including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs), including 351(k) applications (i.e., biosimilars). OPQ also performs the quality assessment of Investigational New Drug Applications (INDs) and establishes quality standards for over-the-counter drug products and facilities.

Dr. Kopcha earned his doctorate and master’s degrees in pharmaceutical science, and a bachelor’s degree in pharmacy from Rutgers University. He also served as an adjunct assistant professor in the Department of Pharmaceutics at Ernest Mario School of Pharmacy at Rutgers.

 

1:15 – 2:30 pm

Session III: Global Solutions and Challenges

Tim Mackey, Associate Professor Director, Healthcare Research & Policy Director, Global Health Policy Institute

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Tim MackeyTim Ken Mackey is an Associate Professor of Anesthesiology and Global Public Health at UC San Diego School of Medicine, the Director of Healthcare Research and Policy at UC San Diego – Extension, and the Director of the Global Health Policy Institute (www.ghpolicy.org).

He holds a BA in Political Science-International Relations, a Masters Degree in Health Policy & Law and also earned his PhD in Global Public Health from the joint doctoral program at UC San Diego – San Diego State University.

Prof. Mackey’s work has been featured in high-impact journals such as Science, JAMA, Nature Biotechnology, the Lancet, Nature Reviews Clinical Oncology, Clinical Microbiology Reviews, and BMC Medicine. His research and expertise has also been featured in major news outlets such as CNN, NPR, Wired, and POLITICO Pro. His work focuses on an array of multidisciplinary topics in domestic and global public health. He also has extensive professional experience including over 10 years experience in the private sector and acting as a consultant for the World Health Organization, the US Department of State, the US Department of Justice, and others.

 

Presentation Takeaways

  1. Machine learning can be used to detect, classify and report illegal online pharmacies, including those illegally selling controlled substances
  2. Test purchase study on antibiotics online has revealed significant patient safety concerns that could exacerbate antimicrobial resistance
  3. Technology, policy, and better stakeholders partnership hold the key to addressing illicit online pharmacies

 

Anne Snowdon, Chair, WIN – University of Windsor

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Anne SnowdenDr. Anne Snowdon is a Professor of Strategy and Entrepreneurship and Chair of the World Health Innovation Network (WIN), at the University of Windsor, Odette School of Business.

Dr. Snowdon leads the work of the first Canadian health innovation centre with formal ties to the U.S., building collaborative partnerships between the two countries to advance the health of populations and accelerate health system innovation in both countries to achieve sustainability, economic value, and productivity by providing support for innovators and entrepreneurs to successfully bring their discoveries to the Canadian, U.S., and world markets.

Currently, Dr. Snowdon is leading over 15 innovation research initiatives across seven Canadian provinces that collaborate with the government, health professionals, private industry, foundations, and families. She served as a member of the Ontario Health Innovation Council and former Vice Chair of the Institute for Healthy Development, Child and Youth Health for the Canadian Institute for Health Research (CIHR).

She was also appointed to the Health Futures Council for Arizona State University, the President’s Advisory Committee on Digital Health Innovation at CIHR, is Vice Chair of the Board of the Directors for Alberta Innovates, a board director for the Ontario Centres of Excellence (OCE), was an Expert Advisor to the Canadian Space Agency focused on Space, Health and Innovation: Emerging challenges, new opportunities and benefits to society. She is also an Associate Professor to the adjunct academic staff of the School of Rehabilitation Therapy at Queen’s University, Adjunct Faculty at the Department of Computer Science at the University of Windsor, and Adjunct Faculty at the School of Nursing at Dalhousie University.

Dr. Snowdon has published more than 150 research articles, papers and cases, has received over $22 million in research funding, holds patents, and has commercialized a highly successful booster seat product for children traveling in vehicles.

She holds a PhD in Nursing from the University of Michigan. She is a Fulbright Scholar, and received the CIHR Partnership Award for her partnership with the automotive industry focused on injury prevention for children. She was most recently awarded the distinction of Fellow of the American Academy of Nursing.

Presentation Takeaways

  1. Convenience and lower prices are the perceived benefits of online pharmacies while receiving wrong or counterfeit medicines are the biggest concerns.
  2. Canadians expect the pharmaceutical and pharmacy industry, as well as the government, to play key roles in online pharmacy regulation to ensure services are safe.
  3. Millennials were up to twice as likely as other age categories to consider visiting an online pharmacy. While only one percent of Canadians have purchased prescriptions online before, one in six respondents say they are at least somewhat likely to make their next prescription purchase online.

Mike Isles, Director, ASOP – EU

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mike islesMike is Executive Director for the Alliance for Safe Online Pharmacy in the EU and also the European Alliance for Access to Safe Medicines – two highly active patient safety organisations. Both focus on making the Internet a safer place to buy medicines and removing falsified medicines from all supply chains. The EAASM also champions patient safety issues relating to unsafe medical practices.

Mike is also European Medicines Partnership Director for International Health Partners, a UK charity whose Queen’s Award for Enterprise for continuous Innovation in 2011, recognises the tremendous humanitarian work sourcing donated quality medicines from the pharmaceutical industry and coordinating delivery via secure supply chain solutions to disaster-struck areas in close liaison with NGOs.

Mike’s professional background is in pharmaceuticals, where he held senior management and director positions covering sales, marketing, commercial and supply chain over a 32-year career.

 

Presentation Takeaways

  1. Collaboration is a critical success factor
  2. Take a hard look at who is creating the demand.
  3. Governments must do more to educate the public about falsified medicines (as I will be talking about the EU Common Logo and under Article 85d of the FMD they are legally obliged too!)

Themes to Explore

  • What data do we have globally on the issue?
  • What tools, training, or technology could help?
  • How can we continue to raise consumer and health provider awareness worldwide?
  • Are there unique global partnerships that should be further developed?

2:30 – 2:45 pm

Coffee Break

2:45 – 3:45 pm

Roundtable Discussion and Next Steps

Moderator: Caitlin Owens, Health Care Reporter at Axios

Panelists: Louise Shelley, John Hertig, Tim Mackey, Elizabeth Miller, and Anne Snowdon

  • Panel discussion focused on emerging research questions 
  • Review various strategies to leverage research for the purpose of crafting policy, educating stakeholders, and improving patient care

3:45 pm

Closing Remarks

Libby Baney, Alliance for Safe Online Pharmacies Global Foundation