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Moving Beyond the Avastin Incident: The Continued Impact of Counterfeit Drugs in the United States March 15, 2012
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Moving Beyond the Avastin Incident: The Continued Impact of
Counterfeit Drugs in the United States
March 15, 2012
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
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
A Public Health Threat
Counterfeit 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
Counterfeiting Incident System (CIS)
Source: Pharmaceutical Security Institute (PSI)
FACT: In 536 incidents, counterfeit products reached licensed wholesale distributors and/or pharmacies in 37 different countries.
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
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
Please Welcome…
Senator Michael Bennet Connie T. Jung, R.Ph., Ph.D., U.S. Food and Drug
Administration's Center for Drug Evaluation and Research
Shay Reid, Pharmaceutical Distribution Security Alliance (PDSA)
Outreach Activities
Consumers Pharmacists & Healthcare Providers Policymakers
Public / Consumers
Consumer Materials Safe Savings brochure SAFE DRUG checklist Facts About Importing
Drugs From Canada FAQs
Languages English Spanish Chinese Vietnamese Tagalog
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
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 SafeMedicines.org
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
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 [email protected]
Both documents are available for free at www.safemedicines.org and also included in the USB you received today
Questions?
Primary Contacts
Michelle Artz, Senior Director, Federal Alliance Development & Public Affairs [email protected] or 202-835-3529 Oversees the day-to-day operations
Tara Goodin, Communications Team Member [email protected] or 202-591-4041 Keeps partners, the media, policymakers, and the public
informed about the dangers of counterfeit drugs
Shabbir Safdar, Communications Team Member [email protected] or 415-683-7526 Creates PSM’s online presence and manages the website and
portals
Thank You
www.SafeMedicines.org
