RFID Standards and Drug Security in the Year Ahead

Back in the 1970s, when bar codes were first being implemented, little thought was given to coordinating the efficient exchange of data in all parts of the distribution "web." Instead, the focus was on distribution "channels" such as retail, healthcare providers, and government/military. Each distribution channel selected its own bar code symbology — UPC, Interleaved 2-of-5, Code 39, HIBCC 39 — for specific applications. At the time, not every reader could read all symbologies.Now, this confusion is starting to be resolved by general use of either of two coding structures, HIBCC or GS1 (formerly EAN/UCC), as well as advances in bar code readers that can identify and read virtually any symbology automatically.Debate over which RFID frequency to use offers many parallels. While pallet- and carton-level applications are embracing UHF (860-960 MHz) in the EPC system, there is a growing belief that high frequency (HF) 13.56 MHz will work better for item-level identification and pedigree. HF tends to perform better in the presence of metal, metallic salts, and liquid — components that are clearly present in many products or packaging configurations.Some studies have shown that UHF will work for pedigree. Others have suggested that HF is preferable. If HF is selected, this divergence will show that there is no clear-cut or universal answer. This would suggest that one type of RFID reader would be used for receiving and inventory to read the EPC tag but another would have be used in the pharmacy to read the pedigree. While location-specific reading does address some of the potential problems, there may be locations where both EPC and pedigree need to be read.Eventually, readers agile enough to work in both frequency ranges will be available — but at a premium. Furthermore, neither frequency solution has yet been fully tested and neither has yet been certified to be harmless. As with bar codes, it will take years to resolve the RFID confusion.The bigger pictureHowever, it's important to look at the entire supply chain and the full range of security options, not just RFID at the item, carton or pallet level. That's because there are several different aspects to ensuring product integrity and correct administration.At the item level, providing the FDA-mandated bar code at the lowest level of packaging will help ensure that the "five Rs" (right medication, right dose, right route, right time, and right patient) are observed at the point of administration. For some, printing on blister packs is admittedly a challenge — but each successful implementation provides lessons that make the next implementation easier. While patient administration may not necessarily be seen as part of supply chain integrity, it is the most critical aspect of it.More conventional thinking needs to focus on the entire supply chain — from packaging through shipment to receipt at the healthcare provider or pharmacy. There is still a lot to be done: data synchronization, implementation of the FDA bar code rule, research into and development of standards for the use of RFID for e-pedigree, implementation of e-seals and other technologies to enable secure tracking of products from production to administration.Maintaining, and increasing, the current momentum will be critical in 2006. Unless the industry acts in concert, individual states may enact legislation or mandate procedures that are not in the best interests of the pharmaceutical manufacturer, distributor, healthcare provider or patient.2006 will highlight other key supply chain issues as well:

• RFID’s impact on drug products:
There is some indication that UHF radio signals can raise the temperature of pharmaceuticals if a package is left in the read field for extended periods of time. This is clearly unacceptable for many pharmaceuticals. On the other hand, there are some indications from limited studies done in Japan that HF may adversely affect electro-cardio stimulators. This is clearly unacceptable in terms of patient care. Using an even lower frequency may not be the answer since longer radio waves (lower frequencies) have a greater effect on such devices.


• GPS tracking:
Product diversion and adulteration doesn't usually happen piecemeal — it tends to be a wholesale event. An entire container or truckload of product is typically the target for these activities. Reading RFID-marked pallets as they're loaded into containers or trailers that can be tracked via GPS-linked transport can identify unexpected or unplanned delays or detours in the container's route. Any unexplained deviation would be cause for immediate concern about the container's contents.

Containers that must be stored for a period of time, such as those awaiting loading onto a ship or transport from a port facility, are subject to tampering. While mechanical seals provide some security, RFID seals can provide instant notification of a container breach or record the time the breach occurred. Knowing when tempering occurs identifies where it occurs and helps pinpoint trouble spots and allows corrective actions to be taken.


• RFID standards progress:
UHF Gen2 standard is nearing publication at the international level (ISO/IEC JTC 1). This is a more comprehensive version of UHF Gen2 than EPC. Vendors are already offering the first production quantities of Gen2 tags, readers and printer/encoders. There seems little doubt that product availability will continue to increase and costs will continue to fall in the coming year.

For 13.56 MHz products, an international standard has existed for several years. There seems to be no indication that this standard will be revised in the foreseeable future. Additional standards may be developed for 13.56 MHz but they will not conflict with the existing standard.

The more important issue is global regulatory standardization to allow the use of RFID devices in every major trading port of the world. Significant strides are being made in this area and indications are that harmonization of frequencies will soon be a reality in the majority of the world. Major differences will continue to exist from country to country in allowable bandwidth and power levels which will limit the effective range and throughput of RFID systems. At present, the U.S. (and other countries in the Americas that adopt FCC radio regulations) enjoy a regulatory environment that allows the most effective use of RFID. Other countries are slowly liberalizing their regulations to provide greater usability.


• E-seals standards:
An international standard for RFID security seals (a.k.a. "e-seals") is under development. Whether this is completed in the next couple of years or not should not limit the use of these devices since they are primarily designed for use by each shipper.