Dr. Timothy Mackey: Clear and Present Danger: Availability of Dangerous, Unapproved and Recalled Drugs Online


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Dr. Timothy Mackey: Clear and Present Danger: Availability of Dangerous, Unapproved and Recalled Drugs Online

  1. 1. Clear and Present Danger: Availability of Dangerous, Unapproved and Recalled Drugs Online 1I Tim K. Mackey, MAS, PhD UC San Diego PSM Interchange October 2013
  2. 2. PRESENTATION AGENDA 1 2 NTI, Unapproved, and Recalled 3 The Internet Pharmacy Ecosystem 4 2 Dangerous Drugs Online: Avoiding the Controversy Solutions? PSM 2 I Interchange 2013
  3. 3. INTERNATIONAL DEBATE Increasing use of the Internet for health, equitable access to medicines, drug and patient safety, intellectual property rights, physician/patient engagement, law enforcement. 3 3 PSM Interchange 2013 I
  4. 4. WHAT HAS BEEN FOUND ONLINE Published Research • • Online availability and safety of drugs in shortage: a descriptive study of internet vendor characteristics. JMIR (2012). • 4PSM Interchange 2013 I Suspect online sellers and contraceptive access. Contraception (2012). • 4 Digital social media, youth, and nonmedical use of prescription drugs: The need for reform. JMIR (2013). Vaccine shortages and suspect online pharmacy sellers. Vaccine (2012).
  5. 5. Searching for Dangerous Drugs Online: Narrow Therapeutic Index Drugs 5 PSM 5 I Interchange 2013 Drugs not approved Drugs subject to Global Recall
  6. 6. NARROW THERAPEUTIC INDEX DRUGS Primary Findings • Danger: Narrow proximity between therapeutic and toxic amounts requires close professional oversight and precise manufacturing. • Challenges: Switching can entail risks arising from variable active ingredient bioavailability. Acceptable list of NTI drugs not well defined. • Availability: Actively marketed for sale. Core list 13/14 (92%, digitoxin available on Alibaba.com); Including Expanded list 24/26 (92%). • Implications: Higher risk of adverse event associated with NTI patients; no physician monitoring; manufacturing processes need to be precise and rely on originator information for BE. Citation Liang BA, Mackey TK, Lovett KM. Illegal “no prescription” internet access to narrow therapeutic index drugs. Clin Ther. 35(5): 694-700 (2013) 6 6 PSM Interchange 2013 I
  7. 7. DRUGS NOT APPROVED Primary Findings • Danger: Obesity is global health crisis. Belviq (lorcaserin HCI, S-IV CS) approved by FDA but was not legally marketed by manufacturer. Weight loss drugs previously identified as being counterfeited. • Opportunity: Research was conducted after FDA approval but prior to DEA scheduling. • Availability: Actively marketed for sale by “no prescription” online vendors (e.g., buybelviqonline.com) and Alibaba.com. • Implications: Drug is not approved, consumers have no idea what they are getting. Could be other weight loss products or counterfeit. Citation Liang BA, Mackey TK, N Archer-Hayes A, Shinn LM. Illicit online marketing of lorcaserin before DEA scheduling. Obesity. 21(5): 861-864 (2013) 7 7 PSM Interchange 2013 I
  8. 8. DRUGS SUBJECT TO GLOBAL RECALL Preliminary Findings • Danger: Drugs subject to equivalent of FDA class I recall may cause serious adverse health consequence or even death. There may be no “authorized” manufacturing of drug. • Challenges: There is no central list of globally recalled drugs (2002-2012). We had to construct such a list for this research from multiple sources. • Availability: Total of 16 (12 oral/4 injectable) identified. 50% marketed for sale “no rx” online. • Additional Findings: Internet ecosystem for recalled drugs is diverse, including heavy presence of affiliates, use of social media, B2B (Alibaba.com) and sites NABP/LegitScript “not recommended”, “rogue”, or “unapproved” Funding Source Part of larger grant through Canadian Social Sciences and Humanities Research Council on counterfeit drugs. Authors: Mackey TK, Liang BA, Aung PS. Work in progress. 8 8 PSM Interchange 2013 I
  9. 9. DANGEROUS DRUG ONLINE ECOSYSTEM Future Challenges Future use of emerging tech of “Deep Web” such as Tor and Bitcoin Affiliate Networks Increasing importance of affiliates when dealing with dangerous drugs Business-to-Business Vendors Legal entity facilitators that wholesale API or finished product to online sellers 9 9PSM Interchange 2013 I
  10. 10. MOVING FORWARD Goals Description Identify High-Risk Dangerous Drugs Identification of drug and health products that can cause serious harm to patients Develop Global Lists Harmonize lists of NTI drugs and recalled drugs for consumer education and safety Identification of Ecosystem Identification and surveillance of entire illicit online pharmacy ecosystem Special and Unique Enforcement Status Enforcement against ALL facilitators in the trade of dangerous medicines Prioritize Dangerous Online Drugs The domestic and international community needs to prioritize identification, surveillance, and enforcement against the online marketing and sale of these clearly dangerous medicines. 10 Done In progress PSM 10 I Interchange 2013 Not started
  11. 11. Questions UC San Diego tmackey@ucsd.edu www.linkedin.com/in/tkmacke y @tkmackey Thank you for listening and we welcome any questions/comments Special thanks to the Partnership for Safe Medicines for advocating for fights against counterfeit medicines 11 PSM 11 I Interchange 2013