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.
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 &quot;how-to&quot; 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.
Beyond Avastin: The ongoing dangers of counterfeit drugs to American patients
Moving Beyond the Avastin Incident: The Continued Impact ofCounterfeit 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 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
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)
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 Administrations Center for Drug Evaluation and Research Shay Reid, Pharmaceutical Distribution Security Alliance (PDSA)
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@example.com Both documents are available for free at www.safemedicines.org and also included in the USB you received today
Primary Contacts Michelle Artz, Senior Director, Federal Alliance Development & Public Affairs firstname.lastname@example.org or 202-835-3529 Oversees the day-to-day operations Tara Goodin, Communications Team Member email@example.com or 202-591-4041 Keeps partners, the media, policymakers, and the public informed about the dangers of counterfeit drugs Shabbir Safdar, Communications Team Member firstname.lastname@example.org or 415-683-7526 Creates PSM’s online presence and manages the website and portals