Comments on Drug Channels: RFID Un-Hype

Most of the benefits of RFID for supply chain trac...

2007-05-31T04:59:00.000-04:00

Most of the benefits of RFID for supply chain track and trace can be had at lower technology risk by using 2D data matrices that can also meet the EPCglobal standard.

RFID is an expensive data carrier that is unfamiliar whilst a 2D data matrix is cheap and well understood.

Dear Anonymous (5/17):RFID may have certain adva...

2007-05-17T16:22:00.000-04:00

Dear Anonymous (5/17):

RFID *may* have certain advantages, but I stand by my statement that it is *not* required or mandatory for compliance.

To be clear, paragraph 4034(i) of the statute does not stipulate how to create "an electronic track and trace system for dangerous drugs that uses a unique identification number." RFID may be better/faster/stronger, but it is inaccurate to say that RFID is legally required by statute.

You are correct that the CA statute calls for serialization at "the smallest package or immediate container." My $0.02: This probably means case-level serialization to start, with item-level serialization being the next logical step.

Disclaimer: I am not a lawyer.

A

Mr. Fein,Your Note about RFID not being required f...

2007-05-17T16:01:00.000-04:00

Mr. Fein,

Your Note about RFID not being required for compliance is misleading. California law does not mandate a specific data carrier.

The California law does mandate manufacturers provide a unique indentifer to Track pharmaceuticals at the Smallest Packaging Level. The tracking data/ information will need to be put in to interoperable electronic system.

The best data carrier to use to provide the unique identification required is to use RFID with serialization. The RFID tag delivers the supply chain levels an increased level of security that is within the spirit of the California pedigree law. We need to design a pedigree system that utilizes the latest in AIDC technology. Lets begin the migration from line-of-sight/bar-code technology.

To Anonymous (from May 16):RFID would only have va...

2007-05-16T09:39:00.000-04:00

To Anonymous (from May 16):

RFID would only have value as an after-the-fact tracing device if the tag is read and authenticated at the end of the supply chain, i.e., the pharmacy. SO far, that does not seem to imminent.

The tags would also have to be applied at the right unit. IOW, tags applied to a pallet would have no value once the pallet is broken down and shipped. Hence, the discussions around mass serialization followed by pharmacy authentication.

Check out the comments on my follow-up post: More RFID Unhype

Adam

On assessing the true value of RFID to drug compan...

2007-05-16T09:20:00.000-04:00

On assessing the true value of RFID to drug companies: Do manufacturers of legitimate drugs not see RFID as a mechanism to fight erosion of their business by the illegitimate suppliers? It seems to me that there is some value in the ability of RFID to allow drug manufacturers to actively police illicit activity. If they want to call the cops at that point they can with the caveat that it is virtually impossible to deter this activity through enforcement and prosecution of illegal traffickers. The bottom line is that all the enforcement in the world will never be able to detract from illegimate marketing of drugs and will not adequately protect the public. This is about protecting commerce, nothing else, and there must be a motivating factor in there somewhere for those paying for RFID to justify their cost.

The reality is that RFID and Pedigree both provide...

2007-04-21T17:34:00.000-04:00

The reality is that RFID and Pedigree both provide data flows that, only if applied properly through detailed analytics, provide enough value to drive proper decision making within pharma. The manufacturers today have a tremendous wealth of information about product flows within their demand side supply chain...namely 852, 867 and 844 data. It is only now that they are beginning to unlock the value of these data sets. RFID and pedigree data flows, when integrated with other data sets and the proper analytics, will finally allow the pharma industry to properly manage inventories, reduce diversion and impact counterfeit product into the legitimate US supply chain.

Kevin Leininger
IntegriChain

With the Board stating that EPCGlobal represents "...

2007-04-20T21:17:00.000-04:00

With the Board stating that EPCGlobal represents "one way" to meet the CA pedigree requirements does that not (especially when EPCGlobal's standards process represents the only thing close to an interoperable system) sound like underground regulation? Specifically, to say one thing meets the requirements when there are no other (presently known)alternatives and then to refuse rulemaking on the matter seems inconsistent with the requirements of CA's APA.

Nick,Great articulation of the difference between ...

2007-04-20T15:58:00.000-04:00

Nick,

Great articulation of the difference between a “compliance cost” (pedigree) versus “business value” (track-and-trace)!

I am only glass-half-full for RFID because the technology has been so oversold relative to its stage of development and actual cross-company supply chain application. Hey, I know that everyone has to sell – I’m just trying to balance out the hype. Read these verbatim quotes from an industry web site's email this morning:

a) “Like other CPG producers, pharmaceutical manufacturers must meet retail or government mandates for RFID tagging at the pallet and case levels.” [Opening paragraph in email]
b) “The U.S. Food and Drug Administration is actively promoting the use of RFID to improve the safety and security of the drug supply.” [vendor statement]
c) “Fight Phonies: Send Counterfeits and Generics to The Jailhouse With [vendor’s name] RFID” [vendor headline]

As for being a glass-half-full kind of guy…depends what’s in the glass. Buy me a pint of Guinness and you’ll see that I can also be a glass empty kind of guy!

A

Adam, calling the HII report "bad news" for RFID m...

2007-04-20T15:34:00.000-04:00

Adam, calling the HII report "bad news" for RFID makes you a glass-half-empty kinda guy. Let me explain: your own citation translates into 31% doing something with RFID. I think that that's an encouragingly high figure.

The next issue of Pharmaceutical Commerce (out in about 10 days) will have a report that includes some of the HII conclusions, as well as reporting from RFID World. One "development" of sorts is that there appears to be a consensus that the January 2009 California deadline is "real"--meaning that industry will have to offer a substantive program by that date. Given how IT/technology projects go, January 2009 is not that far off.

Your comments about the CA regs, RFID and e-pedigree are sort of right, in my view, but there's another element to this. The conflict is not between RFID and e-pedigree, but rather pedigree documentation (whether electronic or paper-based) and a for-real track-and-trace system. Pedigree is mostly a system that trails a product through the supply chain, so that a product and its records arrive at a destination more or less together. Track-and-trace is mostly a database that allows both backward looking views (to produce a pedigree) and forward-looking views to, for example, do better forecasting, inventory management or contract monitoring. That flexibility is where the business value will come from. Pedigree documentation is a negative-value regulatory burden (but necessary); track-and-trace has potential to be a postive-value business practice (while complying with pedigree requirements).

The kicker to all this is that RFID, in its fullest flowering, makes track-and-trace easier to do. You're right--neither pedigree (nor track-and-trace) necessarily depend on RFID. But RFID makes track-and-trace easier to perform.

I recommend the HII report to anyone in the pharma industry who's trying to get a meaningful assessment of what's going on; it presents the business case without the RFID hype coming from many other directions.

See you at TRAX!
--Nick Basta, Pharmaceutical Commerce

Yes, I agree that the regulations are needed in or...

2007-04-20T15:11:00.000-04:00

Yes, I agree that the regulations are needed in order to implement, although I'm note sure how much guidance the CA Board of Pharmacy will provide.

At a March 8 meeting with EPC Global regarding pedigree, a CA deputy attorney general commented that "...there is no requirement for the Board of Pharmacy to adopt the [EPCGlobal] standard...The standard itself is the industry's way to comply with the law." this implies that the Board *may* establish a single standard...or not. (Yes, I'm confused, too.)

Regardless, RFID has been "next year's big thing" every year for the past 5 years. Rapid adoption of RFID by 2009 would be the triumph of hope over experience, whereas it is possible to implement e-pedigree right now.

Given the way California's pedigree law is present...

2007-04-20T14:52:00.000-04:00

Given the way California's pedigree law is presently written, who will they prosecute for violations of the pedigree law if there is no interoperable system? It seems to me that implementing regulation will be required in order to carry out the statute's intent...thoughts?