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Beyond Avastin: The ongoing dangers of counterfeit drugs to American patients


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This presentation was the main portion of a March 15th, 2012 Congressional briefing in Washington DC on the state of counterfeits in America and the details, as currently known, of the fake Avastin incident.

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Beyond Avastin: The ongoing dangers of counterfeit drugs to American patients

  1. 1. Moving Beyond the Avastin Incident: The Continued Impact ofCounterfeit Drugs in the United States March 15, 2012
  2. 2. Comprised of more than 65 non-profit organizations, the Partnership for Safe Medicines is a public health group committed to the safety of prescription drugs and protecting consumers against counterfeit, substandard or otherwise unsafe medicines PSM believes that just one unsafe medicine threatens patient safety… we all must work together to educate and to help protect patients around the globe
  3. 3. About the Partnership Key Messages  Counterfeit medicines do exist  They are not safe  You can take action to avoid them Core Principles  Protect our supply chain  Regulate online drug sellers  Unify in the fight against counterfeit drugs
  4. 4. A Public Health ThreatCounterfeit Drugs… Defraud consumers Deny patients therapies that can alleviate suffering and save lives Can cause great harm and fatalities  Allergic reactions  Heavy metal poisoning  Promote drug resistance strains of diseases Not limited to brand-name, prescription lifestyle drug  Fake versions of generic and over-the-counter (OTC) drugs Global issues with widespread health challenges
  5. 5. Counterfeiting Incident System (CIS) FACT: In 536 incidents, counterfeit products reached licensed wholesale distributors and/or pharmacies in 37 different countries.Source: Pharmaceutical Security Institute (PSI)
  6. 6. Finding Consumers Online Pharmacies  Today, most fake drugs come directly into U.S. homes from fake online pharmacies  According to a study from NABP, 96 percent of the online pharmacies they screened were not safe for consumers Drug Importation  By marking the drugs "for export only," drug exporters can make Canada a post office box for fake or low-quality drugs from China, India, and other countries notorious for ineffective and sometimes lethal products In 2012, 48 percent of counterfeit medicine seizures made by law enforcement were of “commercial” size
  7. 7. Avastin 2012 On Feb. 14, 2012, the U.S. Food and Drug Administration (FDA) and pharmaceutical manufacturer Genentech warned the public that counterfeit versions of the anti-cancer drug Avastin had been distributed in the United States by an unauthorized foreign supplier In a separate communication on the same day, the FDA warned 19 medical practices that purchased medications from the foreign supplier The counterfeit Avastin contained starch, salt, cleaning solvents and other chemicals Did not include bevacizumab
  8. 8. Please Welcome… Senator Michael Bennet Connie T. Jung, R.Ph., Ph.D., U.S. Food and Drug Administrations Center for Drug Evaluation and Research Shay Reid, Pharmaceutical Distribution Security Alliance (PDSA)
  9. 9. Outreach Activities Consumers Pharmacists & Healthcare Providers Policymakers
  10. 10. Public / Consumers  Consumer Materials  Safe Savings brochure  SAFE DRUG checklist  Facts About Importing Drugs From Canada  FAQs  Languages  English  Spanish  Chinese  Vietnamese  Tagalog
  11. 11. International Principles for Drug Safety  Unify in the Fight Against Counterfeit or Spurious Drugs  PSM India  Secure and Protect the Supply Chain  Regulate Online Drug Sellers
  12. 12. Annual Interchange Annual Meeting to discuss challenges and solutions to the threat of counterfeit drugs Attendees and speakers include:  Law enforcement  Government regulators  Academics  Pharmaceutical sector/manufacturers Upcoming Interchange – September 28, 2012  PSM partners receive priority attendance and a reduced registration rate  More details will be available soon on
  13. 13. LEADER’s Guide for Pharmacists  LEADER’s Guide for Pharmacists  Updated and expanded resource about safe sourcing  SAFE Sourcing Guide  Archive of peer-reviewed counterfeit drug research
  14. 14. Introducing…LEADER’s Guides for Physicians & Nurses Physicians and nurses are often in a key role to safely source, auditing the sourcing of patient medication, or spotting counterfeit- induced therapeutic failure LEADER’s Guides already on the websites of the National Association of the Boards of Pharmacy, the American College Health Association, or the Institute for Safe Medication Practices To co-brand or distribute the documents, please contact us at 703-679-SAFE or Both documents are available for free at and also included in the USB you received today
  15. 15. Questions?
  16. 16. Primary Contacts Michelle Artz, Senior Director, Federal Alliance Development & Public Affairs  or 202-835-3529  Oversees the day-to-day operations Tara Goodin, Communications Team Member  or 202-591-4041  Keeps partners, the media, policymakers, and the public informed about the dangers of counterfeit drugs Shabbir Safdar, Communications Team Member  or 415-683-7526  Creates PSM’s online presence and manages the website and portals
  17. 17. Thank