Attendees at the inaugural Interphex India show in September were exposed to the most cutting-edge technologies affecting the pharmaceutical industry. Held in conjunction with the annual Indian Pharmaceutical Association (IPA), the event showcased various applications of radio frequency identification (RFID) in the pharmaceutical market.
Over the course of three days, leading manufacturers in the RFID space, including SAP, Bartronics, IBM, and Infosys presented real-world case studies on how RFID is being used in the pharmaceutical industry. The event also featured in-depth learning sessions led by industry training experts from US-based OTA Training.
The global leader in hands-on, vendor-neutral RFID training, OTA presented informative sessions on the use of RFID for improved identification, supply chain and recall management in the pharmaceutical industry.
Combating Counterfeiting
According to Robert Sabella, OTA CEO and founder, counterfeit drugs represent a substantial threat to public health, putting millions of consumers at risk each year. In fact, the US-based Center for Medicines in the Public Interest predicts that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005. The World Health Organization (WHO) estimates that counterfeit drugs account for 10% of the global pharmaceutical market - and in developing countries, up to 25% of the pharmaceuticals are counterfeit.
"It's a tremendous risk to consumers," said Sabella. "Counterfeit drugs can contain inert ingredients, incorrect ingredients, improper doses of the right ingredients, or ingredients that are either too potent or not potent enough."
To address this challenge, many national regulatory agencies - from the United States' Food and Drug Administration to the Indian National Good Laboratory Practice Compliance Monitoring Authority - are considering e-Pedigree laws to improve verification of drugs. The US FDA has identified RFID as the best solution to provide e-Pedigree and product authentication.
"The legislation is meant to require certain data for all pharmaceutical drugs that will allow verification of their authenticity," said Sabella. "Manufacturers can use RFID to electronically document a medication's chain of custody, based on the manufacturer's name, product name, lot number, expiration date, and shipment source, and a variety of other data."
Once RFID-enabled, the product can be tracked across the supply chain, with electronic documents passing between trading partners based on individual events such as packaging or shipment.
"With this level of visibility, it's possible to secure the supply chain to a much higher degree," said Richard Harden, OTA VP of Training and Certification. "You're tracking the product hand-offs between trading partners in a much more controlled way."
From Identification to Visibility
Beyond simply verifying a drug's authenticity, OTA showed Interphex attendees that RFID is becoming increasingly popular with manufacturers like Pfizer and GlaxoSmithKline for tracking and tracing a product's every movement through the supply chain.
"When applied at the item level, RFID can produce 100% visibility across the supply chain, from serialization to product authentication and e-Pedigree," said Sabella. "Ultimately, the more visibility you have into a process, the better you can baseline metrics and performance to improve that process."
For example, in addition to tagging individual product bottles, cases of drugs can be tagged on a production line, with the data entered into a back-end system that associates the bottles with the case tag. Cases may be read when they're placed on pallets and shipped to a distribution center, and again when they're broken down and placed in inventory. After products are pulled to fill orders, an RFID reader again captures the case and bottle ID, which is associated with order information in the back-end system. The products are read again when a wholesaler receives the shipment, authenticating it and matching it to an order.
"When organizations move from pre-defined process models to event-driven process models, they'll gain tremendous benefits from the automation provided by RFID," said Sabella.
Real-world Improvement: Recalls
OTA focused on one outcome of capturing accurate data throughout the supply chain: the ability of pharmaceutical companies to better manage product recalls. Recalls in the pharmaceutical industry number in the hundreds each year, and the costs can run to the tens of millions of dollars.
An even more significant cost is the damage to a given brand included in a recall. In fact, a University of Wisconsin study estimates lost shareholder value following a recall at 12 times the total cost expense of the recall.
"By enabling manufacturers to efficiently and quickly recall products, RFID saves them money while minimizing risks to the public," said Sabella.
When RFID is used to track both e-Pedigree and individual events in a supply chain, pharmaceutical companies and their partners can trace a particular drug's history and more quickly identify where it may have been contaminated during supply chain process. The technology also provides visibility into the quantity of inventory of certain drug that each company has on hand. Rather than manually seeking out bottles with certain product numbers on shelves and pallets, companies can simply read and identify them with RFID reader, getting drugs off the shelves more quickly and minimizing risks to the consumer.
Interest Increases in RFID
The level of RFID coverage at Interphex India demonstrated an increasing interest in RFID throughout the pharmaceutical sector in India. For its part, OTA Training provided attendees with a healthy dose of RFID education to take back to their organizations, including best practices from around the globe and in-depth examples of how RFID can be deployed to improve processes in the pharmaceutical industry.
For anyone who missed the courses during the event, the company is now offering a pharmaceutical module with more detailed material and hands-on exercises as addition to their normal instructor-led training carried out worldwide.