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Pharmaceutical Manufacturing and Packing Sourcer

Riding the New Wave

Several powerful drivers for RFID-based pharmaceutical serialisation are combining to create a new wave of product tracking potential, as the pharma-driven tag standard meets the financial and technological forces of near field communication. Radio-frequency identification (RFID) for pharmaceutical serialisation should be reconsidered. The passage of time has yielded RFID in a form that has enabled increasing levels of speed, capability and functionality. RFID now exceeds the requirements determined necessary during the pharmaceutical industry’s use-case analysis associated with the pedigree legislation proposed during the mid-2000s. Furthermore, the emergence of hundreds of millions of near field communication (NFC) phones over the next two years suddenly adds a dimension of patient support and interaction which far exceeds the demographic insight considered so desirable a few years ago. This article measures RFID capabilities in relation to serialisation needs, and outlines the step-change NFC will bring to consumer, patient and caregiver support.

Midway through the first decade of the 21st century, the pharmaceutical industry worked diligently to make use of technology that could provide stronger authentication for prescription drugs. Concern was rising over the increasing number of counterfeit drugs being discovered at multiple points in the legitimate drugs supply chain. Due to what was perceived as a slow national reaction to this mounting problem, individual states in the US enacted ‘pedigree’ legislation requiring a paper trail; all parties shipping or receiving drugs verified their shipping or receiving partner in each transaction, and declared in documents the authenticity of drugs during their possession. The accumulated paperwork would accompany drugs to the eventual point of sale to patients or caregivers. The pharmaceutical industry acknowledged the concern over counterfeits, but also indicated that the paper solution was untenable, and that a more automated, database-driven approach was necessary.

Simultaneously, considerable publicity regarding the supply chain utilisation of RFID for consumer products (CPG) and Department of Defense (DoD) supplies drew attention to RFID as a technology that should automatically identify drugs at the shipping or receipt point. RFID would push the data to each custodian’s database, which in turn could be probed to track shipments that may have been compromised. The pharmaceutical industry worked under the umbrella of EPC Global (now absorbed into GS1) to define the use cases. Some shortcomings were noted concerning RFID:

  • The effects of the ultra high frequency (UHF) energy used by CPG/DoD RFID tags on drug efficacy were sufficiently unclear for attention to turn to high frequency (HF) tags
  • Both UHF and HF failed to reveal all drug packages in the totes normally used by order pick distribution. Technically, UHF had shadowing, and HF displayed inductive coupling

Encoding identifying serial numbers on HF tags on drug packaging lines required a measure of time which slowed packaging lines, reducing productivity. The command set used by the prevalent HF protocol of the day was different to the command set used by CPG/DoD UHF protocol, resulting in different detail connectivity at the lower level of data collection.

In response to the shortcomings associated with HF and in consideration of pharmaceutical use, a new EPC Global and related ISO HF protocol standard was drafted – essentially taking the UHF Gen2 command set and anti-collision algorithm and using an HF radio front end. A new standard, ISO 18000- 3m3, has emerged from ISO and was recently ratified in GS1. At least one integrated circuit (IC) supplier is poised to offer the IC by the end of 2011, at a cost lower than other HF ICs.

New Standards Signal Seamless Handset Compatibility

Parallel to the definition and refinement of the pharma-driven tag standard, powerful financial and technological forces have been in play to drive the refinement and ecosystem for NFC. Essentially, standards and hardware have been defined to allow purchase and payment via an embedded HF radio in mobile phones. In 2011, NFC standards had become very public and the emergence of several NFC phones gave commercial and technical credibility to these standards. As many as 50 million NFC mobile phones were estimated to be in place by the end of 2011, and another 200 million plus should be in public hands during 2012. The launch of Google Wallet in San Francisco and New York and the mobile carrier/credit card consortium, ISIS, lend significant credibility to mobile-based NFC as an integral part of consumer commerce this decade. NFC standards encourage at least four consumer (patient/ caregiver) usages of mobile phones:

  • Service discovery – detailed product and companion product information; quick link to social network assessments of products and places
  • Payment – the phone appears as a contactless credit card or transit ticket
  • Smart posters – coupons move directly from display to phone; cross-selling of supporting products
  • Easy pairing – switch to Wi-Fi for higher speed from the carrier; connect to Bluetooth devices, and share directly between NFC phones

Furthermore, in an industrial or commercial setting, associates, contractors and so forth would now have an RFID reader in a device they always have with them, namely their mobile phones, to geo-locate assets and provide observational input or have access to structured guidance.

The final illustration of the functional and technical convergence of ISO 18000 3m3 and NFC is that NFC phone chip sets will start being incorporated into NFC phones with ISO 18000 3m3 during 2012. By the end of the year, ICs designed for pharma serialisation and NFC in hundreds of millions of consumer, patient and caregiver phones will be seamlessly compatible.

Meeting Pharma Serialisation Needs

ISO 18000 3m3 RFID ICs far exceed the functional expectations of pharma serialisation. Sequential individual packages of pharmaceuticals can be encoded and validated with unique serial numbers on packaging lines running in excess of 1000 packages per minute. In addition, the ISO18000 3m3 command set allows bulk encoding of packages already cased at rates exceeding 15 packages per second.

Case level item accounting has also been improved. All item-level serial numbers are readable with any movement of the case. There is no need to manage an associative scheme between items placed in a case before sealing to collect all item IDs on either shipment or receipt of cases, and no cases need be opened to ID all the item serial number on receipt. Fifty-count cases can be interrogated in 330 milliseconds, while distribution totes can be inventoried in 500 milliseconds.

Silicon-based numbering is always harder to replicate than visual-based numbering. With RFID-based serial numbers, multiple layers of diffi culty need to be overcome for duplication to take place beyond the pharma manufacturer’s facility, increasing the strength of the serial number’s authenticity. First the serial number can be password locked, making discovering the password a challenging task for a hacker. Second, RFID ICs carry their own serial number (TID), burned at the silicon fab. A relationship, data or encoding between the serial number and TID provides another barrier. There are other encryption and encoding schemes that make serial number copying or creation diffi cult, but only RFID offers the potential of silicon DNA timing circuits, essentially making the IC unclonable. See the boxed text on Silicon DNATM (page 48).

RFID has an unequalled record in satisfying emerging requirements for accumulating serial numbers upon receipt or at any supply chain transition point. Reading speeds exceed the throughput of today’s processes. Items do not have to be removed from cases to be read. Mixed item reading in distribution totes is done at tote flow rates, at accuracies higher than manual accounting. True process throughput occurs because RFID requires only proximity, not alignment.

RFID also offers the lowest systemic cost for tracking and tracing items. Another major regulated sector – food produce – is considering similar track and trace requirements. Producers and entities involved in distribution are discovering that, in the US, a $0.03 2D barcode costs between $0.05 and $0.10 per tagged item to scan at each transition point. For distributors, even at the lowest 2D barcode cost, $0.10 is added to the tagged cost, $0.05 on receipt and $0.05 on the outgoing shipment. This becomes very expensive when more than one intermediary is involved. RFID trades a slightly higher capital cost for a much reduced operating cost, because data input requires no human intervention.

In the previous deep drive during the past decade, pharma manufacturers were adamant about gaining more demographic insight into the patient and physician base regarding their drugs. NFC phones certainly transform the opportunity for patient insight and support – which can now be direct with the use of ISO18000 3m3 tagged patient packages. That is, rather than simply being an authentication mechanism in the supply chain, RFID tagging can provide patient support, faster instruction to call a physician, individual patient profiles – anonymously or with permission granted – and even marketing. The patient/caregiver decides the level of identity they will convey to the pharmacy or drug manufacturer.

Fully Leverageable Technology for Complete Disease Management

NFC and RFID tagged prescription offer a mechanism for prescription compliance that has been unattainable until now. Statistics related to the consequences of prescription non-compliance, such as the following from the US Center for Disease Control, can be significantly reduced using the cell phone in your purse, pocket or beside your bed. These show that:

  •  Annual excess medical costs are in excess of $290 billion
  •  Annual deaths number more than 300,000
  •  Emergency room visits equate to over 20,000,000 per year
  •  Hospitalisations total over 10,000,000 per year

By tapping the prescription package each time a pill or capsule is taken, the NFC-phone registers timely compliance and contacts the patient caregiver when a dose is missed, and medical personnel when missed doses are a concern.

NFC phone-based compliance will progress to more complete disease management where the phone, via NFC-paired Bluetooth, will report the results of analytical devices such as glucosemeters and scales. Food and lifestyle choices can be reported for a more complete level of support. With extreme healthcare cost pressure, payers, providers and patients will reward, support, and expect the mechanisms that NFC phones will enable.

But pharmaceutical packagers, distributors and pharmacies need to commit to RFID serialisation, because it provides many more mechanisms to lower healthcare costs than the lowest application cost mechanism for the singular regulated requirement of serialisation. Payers need to acknowledge the small added cost for RFID serialisation over the 2D barcode to incentivise its use in anticipation of much larger cost savings. And providers need to reinforce the cost and health benefits of NFC-supported disease management. RFID is the most accessible technology available, given the already committed capital and process investment requirement to achieve serialisation.

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Randy Stigall currently serves as a Director for UPM RFID’s North American business, responsible for Emerging Applications. He has been working with UPM RFID since January 2002, having previously worked for Procter & Gamble for 31 years in both facility engineering and package development. He has contributed to multiple standards and guidance documents related to RFID utilisation, beginning with MIT’s AutoID Center in the 1990s to subsequent EPC Global and AIM activities, and now GS1. Randy has been involved in several projects where plastic parts, packaging and labelling have been integrated.
Randy Stigall
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