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      RFID - A prescription for pharma counterfeit

      Posted AtExpress Pharma Pulse

      Counterfeit drugs are a huge problem not only to our society but also to the Pharma industry globally, Ravi Mathur gives offers a way outAccording to US Food and Drug Administration (USFDA), approximately 88 percent of the drugs entering USA are unapproved. India accounts for 14.3 percent, Thailand 13.8 percent and Philippines eight percent of these drugs. World Health Organization (WHO) estimates the sale of counterfeit prescription drugs is potentially a $26 billion a year illegal business. As a major exporter and manufacturer of pharma drugs, this affects the brand equity of India in global market.

      USFDA recommended Radio Frequency Identification (RFID) as way to thwart illegal drug trafficking. Several states, including Florida and California, passed laws requiring pharmaceutical companies to track drug shipments as they move through the supply chain. In its report titled "Combating Counterfeit Drugs - A Report of the Food and Drug Administration" - February 2004, FDA clearly brings out RFID as the killer solution to combat the counterfeit problem.

      The pharmaceutical industry is a step ahead in the application of RFID in its supply chain. The first to focus on tagging at the item level. The use of RFID was under State mandates and Federal rules to secure the supply chain from counterfeit products. The mandates do not apply just to manufacturers but to the entire pharmaceutical pipeline, which comprises of drug makers, distributors and wholesalers, drugstores and hospital pharmacies that actually fill prescriptions.

      Electronic Product Code

      Electronic Product Code (EPC) based RFID technology uses RFID tags affixed on cases or consignments and a serialised EPC for identification to facilitate detection of counterfeit pharma drugs and medical supplies globally. This benefits all the stakeholders like pharma manufacturers, health regulators and the pharma distribution chain covering chemists and druggists, stockists and the most of all-the consumers.

      EPC is an innovation undertaken by Auto-ID Center, Massachusetts Institute of Technology (MIT), Boston which was funded and sponsored by USFDA, Baxter, Reckitt Benckiser, Abbott Labs, Pfizer, Johnson & Johnson amongst other leading companies across industry segments.

      Manufacturers, distributors and retailers see RFID as a way to create an electronic pedigree, by placing tags with an EPC, or unique serial number, on every bottle and vial of prescription medication. The tags could be read and the validity of the drugs authenticated at every step in the pharmaceutical supply chain.

      The pharmaceutical industry is also getting pushed into RFID by mandates from Wal-Mart, which has a pharmacy division, and US Department of Defense (DOD). The retailer and DOD have ordered their largest pharmaceutical suppliers to start tagging products as a cost of doing business.

      Healthcare Life Sciences Business Action Group

      EPCglobal formed an action group called Healthcare Life Sciences Business Action Group (HLS BAG). It comprises of leading manufacturers such as Abbott Laboratories, Barr Laboratories, Johnson & Johnson, Pfizer, Procter & Gamble. It has two pharmaceutical wholesalers, Cardinal Health and McKesson; and two retail pharmacies, CVS Pharmacy and Rite Aid, industry trade associations including the Healthcare Distribution Management Association (HDMA) and National Association of Chain Drug Stores (NACDS). Sanofi-Synthelabo, Walgreen and Wyeth have also joined the group recently.

      It was formed to facilitate the adoption and implementation of EPC based RFID technology in the pharma sector. Participation in this is open to all EPCglobal member companies world-wide.Accenture co-ordinated an RFID pilot, beginning in October 2003. The RFID pilot involves a number of manufacturers like Abbott Laboratories, Barr Laboratories, Johnson & Johnson, Pfizer and Procter & Gamble; and distributors like Cardinal Health and McKesson and retailers like CVS and Rite Aid. It also has Healthcare Distribution Management Association (HDMA) and the National Association of Chain Drug Stores (NACDS) co-operated to tag, ship, receive, handle and trace nearly 13,500 prescription drug bottles. The project ended in late April, and Accenture is continuing to work with the participants individually.

      The point of the pilot was to assess the business value of RFID technologies, standards and processes and to prove that RFID could be implemented in the pharmaceutical supply chain.

      Drug makers Test Item-Level Tagging

      FDA's endorsement of RFID technology coupled with a mandate from Wal-Mart that impacted manufacturers of Schedule II narcotics spurred Purdue Pharma, to start experimenting with RFID tagging. In November 2004, it began shipping individually tagged bottles of OxyContin, a Schedule II painkiller, to Wal-Mart. It became the industry's first company to tag individual bottles of pills on the assembly line, rather than resorting to a slap-and-ship operation. Pfizer's goal is to thwart counterfeiting by applying RFID-tagged labels to Viagra bottles.

      GlaxoSmithKline (GSK) has plans within the next year to put RFID tags on certain pharmaceutical products it deems susceptible to counterfeiting or theft. GSK has identified several top priority drugs as candidates for its pilot, including Combivir, Epivir, Retrovir, Trizivir, Ziagen and Zofran. GSK has started tagging some pallets and cases of consumer healthcare products that it ships to Wal-Mart.

      Improving the Supply Chain

      Optimising the supply chain was one of the biggest challenges of the healthcare sector. It globally loses $ two billion due to overstock and expiry. RFID helps in optimising supply chain which would enable to achieve 30 percent stock reduction, 30 percent increase in value added time and seven percent reduction in supply chain costs.

      It also helps in FIFO management, recalls of expired drugs, real-time tracking of expensive and critical instruments, restricting the access of drugs to authorised staff, accurate matching of test specimens to the patients, reduction in medical errors.

      Medical errors are a big concern area for this sector. Approximately 75,000 patients die in USA alone each year from medical errors, which is caused by patient misidentification or medication misiden-tification. This can be eliminated altogether by the use of RFID tags, which can be placed on test specimens and accurately linked to a patient's records.

      Deployment in India

      Within India, Ranbaxy is the first company to affix EPC/RFID tags in response to Wal-Mart directive effective since January.

      Since India has positioned itself as a major supplier of pharma drugs, Indian companies need to initiate deployment of EPC/RFID tags by understanding the technology, running pilots etc well before it comes a mandate.

      October 14, 2005


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