In response to the growing problem of counterfeit drugs introduced in the US drug supply system, the National Association of Chain Drug Stores (NACDS) has submitted a report to the US Food and Drug Administration (FDA) as a commentary on policy issues surrounding prescription drug counterfeiting, and offering recommendations on anti-counterfeiting measures, including the use of RFID technology.
The report submitted to the FDA, entitled ''Industry Points of View on Counterfeit Prevention'', includes both short- and long-term recommendations, with a multi-faceted approach to addressing prescription drug counterfeiting, including:
A Classification System: The FDA and the industry should establish a system by which prescription drugs are categorised based on counterfeiting and patient safety risks. The system would prioritise and focus resources on the drugs most vulnerable to counterfeiting.
Tracking and Tracing: Similar to imported food regulations already in place, this temporary procedure would implement a ''one-step-back, one-step-forward'' record-keeping system, ensuring drug authenticity for very high risk drugs. Every member of the supply channel would track the immediate source and recipient of drug products. As RFID (radio frequency identification) technology progresses, a ''start to finish'' digital programme could be implemented for the tracking of all prescription drugs throughout the entire drug distribution channel.
Anti-Counterfeiting Packaging: The FDA should provide industry guidance on facilitating multi-level measures built into packaging - helping to combat counterfeiting of high risk drugs.
Strict Licensing: States and the FDA could implement more stringent licensing requirements on wholesalers and drug re-packagers - including tougher penalties and frequent inspections for all distributors in the prescription drug channel.
Importation Law Enforcement: State and federal agencies should work in conjunction with the FDA to enforce existing importation laws.
Additionally, the report recommends that the FDA should implement an aggressive consumer education campaign on safety risks and the illegality of drug importation. NACDS president and CEO, Craig Fuller, confirmed that the association will continue working with the FDA to find the best ways to combat prescription drug counterfeiting. 184.108.40.206 This article is copyright 2003 UsingRFID.com.
Prescription drug counterfeiting is difficult to detect and investigate. The International Federation of Pharmaceutical Manufacturers Association (IFPMA) in Geneva estimates that 2% of the drugs sold each year are counterfeit. Additionally, the World Heath Organisation (WHO) estimates that 5 to 8% of the drugs sold worldwide are counterfeit. The NACDS report represents the recommendations of chain drug stores, suppliers, wholesalers and manufacturers.
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