RFID at Work in Pharma

The US Food and Drug Administration (FDA) acted in June of 2006 to implement legislation to protect the safety of prescription medicines. The new rules require drugs to have Pedigrees, or records, which track their path from the factory to the consumer. The US Congress passed the Drug Pedigree Law 18 years ago in order to guarantee the authenticity of drugs. Tracking and authenticating pharmaceuticals is enforced throughFDA legislation.

The FDA legislation is to help protect users of pharmaceutical drugs throughout the entire supply chain worldwide. It is designedto benefit our entire global village.

The Pedigree Law is designed to ensure that consumers are receiving an authentic product from the drug manufacturer, distributor,hospital, local pharmacy, and doctor.

The Asia Pacific region should implement the Pedigree legislation. It will ensure the safety of consumers taking medication. They deserve to know the drug they are purchasing and placing into their bodies is the correct medication and not a counterfeit ordiverted drug.

This legislation would also help get recalled medication off the shelf, back to the manufacturer to be destroyed in a very timely manner. This further ensures the safety ofthe consumers.

However, some of the rules for implementing the law were never finalized. Loopholes left the door open for counterfeit medicines to enter the mainstream medicine supply andthe shelves of trusted local pharmacies.

Drug Protection

Drug counterfeiting is a US$32 billion- a-year business and as much as 10% of drugs worldwide are counterfeit. According to World Health Organization estimates,the business has grown 30 to 50% annually. Counterfeit drugs look the same as the realthing but they do not contain the essentialactive ingredient or might have contaminants.

There have been numerous documented cases in the Asia Pacific (AP) region of counterfeit medications finding their way onto the store shelves and unsuspecting bodies of AP consumers. RFID can help authenticate and reduce diverted medications from entering into the mainstream pharmaceutical market in the AP.

Increased control of the logistics chain aims at preventing counterfeit drugs from ending up in consumers’ hands. The new Pedigree regulation will ensure the tracking and authentication of pharmaceuticals.

In practice, this means drug distributors are required to document the chain of custody as drugs move through the distribution channels. Each individual package or bottle needs ID information so that it can be identified on its way from the factory to the consumer. The information includes confirmation that the product is genuine, has not passed its expiry date, and is not subject to a recall.

The FDA has recently reaffirmed its recommendation that Radio Frequency Identification (RFID) technology be used widely throughout the pharmaceutical industry by 2007.

The FDA is encouraging the pharmaceutical industry to adopt RFID as a tracking technology to create electronic pedigrees, or ePedigrees. Technically, the FDA is mandating the use of electronic track and trace technology, of which RFID is the most widespread application.

US Expected to Adopt RFID First

“The US represents 60% of the pharmaceutical industry worldwide. Decisions made in the US will, therefore, eventually affect European legislation and practices. Counterfeiting is a big problem, even in Europe,” says Samuli Strömberg, VP marketing, RFID at UPM Raflatac.

“The US will most likely be the first to adopt RFID in the pharmaceutical industry. The strongest drivers for implementing RFID are in the US because of the FDA’s decision to implement the Pedigree Law. They also have the most homogenous legislation regulating the pharmaceutical industry.”

“The pharmaceutical industry is a vast market where changes don’t happen overnight; one year is a short time. However, it is likely that all major companies will at least test RFID technology,” explains Strömberg.

He also notes that the pharmaceutical industry is still debating two differing RFID technologies—the newer long-range Ultra High Frequency (UHF), and High Frequency (HF), which has been around for years.

RFID Feasibility

With RFID, drug identification can be achieved reliably and rapidly at each point of the supply chain—from the factory to the consumer. There is no need for huge investments or additional manual labor.

The costs involved for using RFID technology are minimal compared to the benefits they bring. Item level tags, readers, and integrated software are the main components and investment required.

An ePedigree with complete tracking history staves off counterfeit products and gray distribution channels. As authentication makes counterfeiting difficult, it also serves to protect brand value. In addition, tracking can improve the process efficiency of each supply chain partner by making receiving and delivering goods easy and fast.

RFID is also a tool for a quick and efficient product recall management process. Companies testing RFID have praised the system for its merits in supply chain collaboration and open data sharing, where authorized parties are allowed to monitor the documented pedigree information.

Testing RFID

Many of the global top-ten drug manufacturers have either deployed RFID projects or are in the process of doing so. Some US drug companies have already initiated their own rollouts of RFID to track and trace their products, most notably Pfizer, maker of Viagra. GlaxoSmithKline, Brentford, UK, has also designed its RFID supply chain project. These high-profile pharma RFID pilots are not only for ePedigree but also for business improvements, ROI-driven adoption.

UPM Raflatac is a partner in many of the RFID pilots currently underway in the pharmaceutical industry. In a trial involving 44 UK pharmacies, for example, Aegate’s RFID and bar code tagging system helped reduce dispensing errors and intercept counterfeit drugs. Aegate tagged products from six drug manufacturers including Merck, Novartis, and Schering Health Care.

Asian companies are watching the progress of RFID implementation closely in the world’s largest pharmaceutical market, the US. Asia Pacific companies are taking a cautious approach before adopting and they will be able to learn the best direction to take from the lessons of the numerous pilot projects going on in the pharmaceutical market.

The success rate using RFID is still being evaluated as large pharmaceutical firms, distributors, retail pharmacies, hospitals, and doctors continue their evaluation of pilot projects and best practices in the US and Europe. PA

Encouraging Asia to Adopt RFID in Drug Protection More can be done to make the use of radio frequency identification (RFID) in Asia’s pharmaceutical industry more attractive. When considering RFID adoption, the safety of consumers in Asia should be the first and foremost concern for Asian companies. RFID is a more accurate method of tracking and authenticating medication throughout the Asian supply chain, which can help to prevent outdated, or counterfeit medications from reaching patients. Case studies have shown the information available from RFID integration is achieved faster and more accurately than bar code methods used in the past. There is less product diversion, counterfeiting, and reduced out of stock situations for critical medicines. These are the key factors and major benefits of using RFID technology. EPCglobal is working to establish standards for RFID products, readers, software, and protocol. Achieving global standards will help ensure item level products are able to comply with the Pedigree legislation and protect consumers in the Asia Pacific region. The goal is product safety worldwide.

UPM Raflatac has supplied tags for a pilot program by Finnish drug manufacturer Orion Pharma. This pilot program is unique in Europe as it involves all the different parties in the supply chain including the packaging manufacturer. Orion says the tagging, tracking, and authentication of individual items was successful and the companies gained an insight into how to use RFID to track raw materials and packaging in their own manufacturing processes. The company says it will start item-level RFID tagging at some point in the future. When deploying RFID, it is important to ensure that the materials, packages, packaging hierarchy, and positioning of tags are suitable for high frequency or ultra-high frequency tags. Data administration and systems used must be adjusted throughout to accommodate RFID use, including rules for access and modification rights.

Scott McFall, Business Development Manager, Pharma, UPM Raflatac, Tampere, Finland

Drug counterfeiting.

FDA mandating the use of electronic track and trace technology.

Customers deserve to know the drug they are purchasing.