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| Protecting Patients from Illegal and Unsafe Medicines |
Combating Drug Counterfeiting & Trafficking
Presentations available to all visitors on completing the SignUp to the website.
Conference Call discussion – 08.00 PST (= 11am New York, 5pm London, 6pm Zurich as European summer time starts one week ahead of the US in 2006) 30 March 2006.
| Discussion Leaders:
Hellmuth Broda (Sun Microsystems), Dietrich Heinicke (CADAC GmbH), Liz From (Sun Microsystems), and Jim McKiernan (McKiernan Associates)
Presentations
RFID in the Pharma Industry, Jim McKiernan, McKiernan Associates More Information....
Sun RFID Solution for Drug Authentication, Liz From and Vivek Khandelwal, Sun Microsystems Inc. More Information....
ProIdent – Open System for combating counterfeit drugs, Dietrich Heinicke, CADAC GmbH More Information....
Identity Management in the Life Sciences: Compliance, Privacy, Information Life Cycle Management, Dr. Hellmuth Broda, Sun Microsystems Inc. More Information....
The growth in the manufacture and trade of counterfeit drugs threatens both global health and the lives of individual patients. Illegal drugs cleverly disguised to closely resemble legal brands can trick patients and pharmacists and may have poor quality control, lack active ingredients, and contain ineffective or harmful ingredients. A patient treated with such a drug does not obtain proper benefit and may be at risk of loss of life. Additionally, illegal drugs with reduced concentrations of active ingredients resulting in incorrect dosage administration, can contribute to the generation of drug resistant bacteria, virus and parasites, thus threatening global health.
Counterfeit drug sales, as recently reported by the Centre for Medicines in the Public Interest, are growing at a rate of 13 percent and are projected to reach $75 billion by 2010. In addition to the damage caused to patients and the legal pharmaceutical industry, such income can also be used to fuel the activities of criminal and terrorist groups.
To tackle the issue of Drug Counterfeiting the FDA Counterfeit Drug Task Force was established in 2003 and issued a number of recommendations in its 2004 report on “Combating Counterfeit Drugs”. One of its recommendations was the introduction of track-and-trace technology such as bar coding and radiofrequency identification (RFID) tagging as a roadmap for ensuring drug product safety from drug production through legitimate distribution channels all the way to the patient.
In this program we discuss current issues and solutions in the introduction of new technologies and processes for ensuring the legality and safety of drugs obtained by patients. We examine the use of electronic labeling, SPL, RFID-tagging, barcoding and automatic product checking to track product throughout the supply chain. New IT-based approaches to security and privacy protection such as federated identity management can be integrated to secure consumer-related information. Questions addressed by this group include:
What are the challenges and barriers to adoption of new technological approaches to better ensure the legality of prescription drugs in the supply chain? What approaches should be used for generic drugs?
What are the predicted costs of investment in systems deploying these new technologies?
What are the potential impacts of further enhancements to the new FDA’s SPL regulations on ensuring correct and legal product dispensing? What is the situation with regards to new European regulation?
How do we protect against new counterfeiting of such label and microchip technologies? Can we be sufficiently confident in the security of the IT systems?
How do we protect against the delivery of drugs through illegal distribution channels such as supported by the Internet, mail order, cross-border delivery or poorly policed or unregulated markets?
What new regulations, laws and international agreements are required to provide better global protection of the supply chain against counterfeit medical drugs and products?
How can global collaboration and cooperation approaches between industry, governments and consumers best support the fight against illegal and counterfeit medicines? | |
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