The Case Against RFID In Pharma

It is pretty clear that there is not much interest in the use of Radio Frequency IDentification (RFID) in the pharmaceutical supply chain because every time I publish an essay in RxTrace about some aspect of it, there is a drop in readership.  So at the risk of taking another hit in readership, let’s take

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5 thoughts on “The Case Against RFID In Pharma”

  1. It may be difficult to justify the use of RFID in the supply chain for all types of pharmaceuticals, but there is at least one category of drugs that would benefit ALL three segments of the pharmaceutical supply chain: Controlled Substances, as regulated by the Drug Enforcement Administration (DEA). This includes many types of the drugs that have a significant abuse potential and therefore require a higher degree of regulatory control (e.g., narcotics, sedatives, hypnotics, etc.).

    Each of the three pharmaceutical supply chain segments spent a lot of effort keeping a precise count of every controlled substance manufactured, distributed, and dispensed. The use of RFID would allow this accountability aspect to be done using automation, not humans.

    An added bonus beyond supply chain efficiency is that the use of RFID tracking for controlled substances could bring a huge Patient Safety benefit by further preventing the “holes” in the current systems that make it too easy for at risk individuals in the supply chain to gain access to theses drugs. By making it more difficult for people to gain access to these drugs, fewer people will become impaired and the patients they take care of will not be impacted.

    If there was ever a place to begin the implementation of an RFID Supply Chain Solution, controlled substances is the obvious place to begin. It’s a winner for all segments and it will positively improve patient safety.

    1. Ray,
      Great point and well said. I agree with you. In that case, RFID tags should be added to all controlled substances while keeping the 2D barcode used for DSCSA compliance, just like the apparel use case. In that way the industry would not necessarily need the approval of the FDA since the 2D barcode would meet the existing requirements of the law and the RFID tags would be used to more efficiently meet the DEA inventory requirements. Companies could then test out supply chain RFID use cases (receiving/shipping) using a controlled subset of their product lines to determine if/when it makes sense to widen its use outside of class II drugs. How do we get manufacturers of class II drugs to put RFID tags on their drug packages in addition to the 2D barcodes, both with the same serial number encoded in them?

      Dirk.

  2. Fully agree…. now if we could get the S. Korea regulatory agency to drop RFID as an product identification option… it would much help to convince some local CMOs that happen to also own IT subsidiaries from pushing their RFID products regardless of value… 🙂

  3. Dirk,

    While you could start with DEA Schedule II medications (e.g., the more potent narcotics like morphine, oxycodone, fentanyl), my opinion is that it should include ALL of the DEA scheduled controlled substances. My reason is because the accountability and precise record keeping requirements for the medications in all DEA schedules are quite similar and having a “common system (i.e., with RFID trackability and tracing) provides a solution that meets the needs for all of these types of medications. Most hospital pharmacies and many high-volume retail pharmacies use some type of secure storage cabinets. Adding RFID tags to all DEA Scheduled Controlled Substances would provide the needed justification to add the ability to use RFID Cabinets to store these items in pharmacies. This would greatly decrease the opportunity for common recordkeeping errors and create a system that would be much less prone to diversion than current systems. Adding RFID tags to DEA Scheduled Controlled Substance would be a “tipping point” in the management of controlled substances and the prevention of diversion.

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