On February 26, 2004, the FDA published its final rule on “Bar Code Label Requirements for Human Drug Products and Biological Products”. According to the Agency, “Bar Codes will allow health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time. This new system is intended to help reduce the number of medication errors that occur in hospitals and health care settings.”
The Bar-Code rule requires linear bar codes on most prescription drugs and on over-the-counter drugs commonly used in hospitals and dispensed pursuant to an order. The bar code is required to contain, at minimum, the drug’s National Drug Code (NDC) number, which uniquely identifies the drug. The rule also requires the use of machine-readable information for blood and blood components intended for transfusion. The machine-readable information must include, at a minimum, the facility identifier, the lot number relating to the donor, the product code, and the donor’s ABO and Rh.
During the same month, February 2004, the FDA’s Counterfeit Drug Task Force issued its report on “Combating Counterfeit Drugs”. This report called for the implementation of Radio Frequency Identification (RFID) technology to allow the tracking of pedigree and mass serialization for all drug products. The Agency set forth a phased approach to the implementation of RFID technology starting at the case and pallet level for products likely to be counterfeited and progressively including all products at the case, pallet, and package level by 2007.
In February of 2006, the FDA conducted a Counterfeit Workshop in Bethesda, MD to get an update from stakeholders on the status of RFID implementations. Affected stakeholders, including manufacturers, distributors and pharmacists, presented progress made and concerns associated with RFID and e-Pedigree initiatives. During my remarks to the Task Force, I stated that RFID technology should be used as an enabler, not a silver bullet. I conveyed the agency’s role to set regulatory requirements, gathered in cooperation with all affected stakeholders. However, in my opinion, the FDA should not mandate specific technologies to be utilized to achieve compliance.
In June 2006, the task force issued its update on the FDA Counterfeit Drug Task Force Report. The agency admitted that although in 2004 it was optimistic that widespread implementation of e-pedigree was feasible by 2007, unfortunately, this goal most likely will not be met. The report went on to say:
“…it is clear from our recent fact-finding efforts that the voluntary approach that we advocated in the 2004 Task Force Report did not provide industry with enough incentives to meet FDA’s deadline.
We continue to believe that RFID is the most promising technology for electronic track and trace across the drug supply chain. However, we recognize that the goals can also be achieved by using other technologies.
Based on what we have recently heard, we are optimistic that this hybrid environment of electronic/paper and the use of RFID/bar code is achievable in the very near future. We believe that efforts to ensure that hybrid pedigrees are secure and verifiable should be a priority consideration.”
Is this a case of one step forward and two steps back? I don’t believe so. I see it as a net gain for all stakeholders, especially patients. The FDA estimates that the bar code rule, once implemented, will result in more than 500,000 fewer adverse events over the next 20 years.
Hospitals have recently made major investments in Bar-Code systems to comply with these regulations and minimize medication errors. Asking them to now reinvest in RFID technology without realizing the benefit of Bar-Codes would be a mistake.
As the saying goes, A Bar-code in the hand is worth two RFID tags in the bush.
Copyright 2006 Daniel R. Matlis – AXENDIA