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. Moving Beyond the
Avastin Incident:
The Continued Impact of
Counterfeit Drugs in the United States
March 15, 2012
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. 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. 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
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. 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. 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.
9. 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)
11. Public / Consumers
Consumer Materials
Safe Savings brochure
SAFE DRUG checklist
Facts About Importing
Drugs From Canada
FAQs
Languages
English
Spanish
Chinese
Vietnamese
Tagalog
12. 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
13. 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
14. 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
15. 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 editors@safemedicines.org
Both documents are available for free at www.safemedicines.org
and also included in the USB you received today
17. Primary Contacts
Michelle Artz, Senior Director, Federal Alliance
Development & Public Affairs
michelle@safemedicines.org or 202-835-3529
Oversees the day-to-day operations
Tara Goodin, Communications Team Member
tara@safemedicines.org or 202-591-4041
Keeps partners, the media, policymakers, and the public
informed about the dangers of counterfeit drugs
Shabbir Safdar, Communications Team Member
shabbir@safemedicines.org or 415-683-7526
Creates PSM’s online presence and manages the website and
portals
These fake drugs may consist of anything from chalk, powdered concrete, and boric acid (or worse) and are sold as if they were real drugs
Sept 2004 FDA – cGMP 1 CFR 211.42(b) states, in part, that “The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination.” 21 CFR 211.42(c) states, in part, that “Operations shall be performed within specifically defined areas of adequate size. There shall be separate or defined areas or such other control systems for the firm’s operations as are necessary to prevent contamination or mixups during the course of the following procedures: * * * (10) Aseptic processing, which includes as appropriate: (i) Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable; (ii) Temperature and humidity controls; (iii) An air supply filtered through high-efficiency particulate air filters under positive pressure, regardless of whether flow is laminar or nonlaminar; (iv) A system for monitoring environmental conditions; (v) A system for cleaning and disinfecting the room and equipment to produce aseptic conditions; (vi) A system for maintaining any equipment used to control the aseptic conditions.” 21 CFR 211.46(b) states that “Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature shall be provided when appropriate for the manufacture, processing, packing, or holding of a drug product.”
Based on its assessment of more than 1,000 Internet drug outlets selling medicine online, the National Association of Boards of Pharmacy (NABP) found that 97 percent of these sites appear to be operating out of compliance with state and federal laws or established patient safety and pharmacy practice standards.
S.A.F.E. D.R.U.G.—An 8-Step Check List for Medicine Safety: Our "how-to" guide helps consumers identify and protect against counterfeit medicines by showing patients how to judge whether their medications are safe and provides tips on what to do if a drug has been compromised. Safe Savings: Our free brochure shows consumers how to save money on their prescription drug costs without compromising safety. Frequently Asked Questions (FAQs): This collection of questions presents a quick overview of counterfeit drugs and their global threat. This easy-to-use document provides members with key information about counterfeit drugs to easily share with consumers and/or constituents.