How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2

Last week I published an overly long essay about how the supply chain provisions of the new U.S. Federal DQSA will and won’t protect the pharma supply chain.  Believe it or not, I had more to say on the subject, but because that essay was already too long, I withheld my additional thoughts until now. 

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5 thoughts on “How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2”

  1. Compared to the California e-Pedigree regulations, the new DSCSA regulations do not do very much for the Pharmacy purchasing drugs to assure that what they have received from their supply is “safe”. Assuming that the parties that counterfeit drugs are going to get more sophisticated with time, they are going to leave little opportunity for your average pharmacy receiving products to “suspect” that there might be a problem. Combine that with the fact that your average pharmacy receives hundreds of items each day and you create an environment where other issues that need handling will take a higher priority.

    In some regards, this reminds be of the driver’s license check that occurs when someone gets pulled over for a possible driving infraction. Currently, when the driver is stopped, the police officer obtains the driver’s license and “runs it” (i.e., enters it into the Department of Motor Vehicles, DMV, database). The system responds with history information about that particular driver, including whether or not the license information is valid. To me, that sounds like the previous California e-Pedigree system; everything is checked as it comes to the person at the point of the stick (the pharmacy in this case, the police officer in the DMV example).

    Using the police stop analogy mirrored after the new DSCSA regulations, the police officer would only “look at the driver’s license” and as long as it “looks OK” nothing else would be done. You won’t catch many crooks that way and, in fact, it may create the opportunity for more crooks, since it is easy to beat the system. This all sounds like a giant STEP BACKWARDS to me. This whole issue of CPU cycles is STUPID. We have computer systems today that can easily handle the volume of transactions needed to support real-time verification similar to what California was proposing (if you don’t believe me, talk to Amazon, they’ve figured it out).

    Most modern pharmacies (particularly hospital pharmacies), scan items that come into the pharmacy to load them into the pharmacies inventory management system and to check what the distributor provided to them. I would be designing a system that at the point of scanning the product into inventory, that it would automatically send a PIA (product identification authentication) Verification request to the vendor. I would also demand that the primary drug wholesaler that I did business with would also be doing the same PIA verification for EVERYTHING that they brought into their system. This is the only way that we are going to be able to protect the patients that we (healthcare providers) take care of. Without that type of verification, we will be following my STUPID DMV license checking mechanism which is designed NOT to catch problems before harm can be done to the general public.

    1. Ray,
      I like your driver’s license check analogy. The DSCSA does not seem to limit what it is that may cause a member of the supply chain to feel suspicious about a drug package. Pharmacies that buy from sources other than a direct-purchase wholesaler may wish to exercise the manufacturer’s PIA service for the first few shipments received and then periodically as a general practice. I suppose nothing prevents them from doing that with every drug they receive, regardless.

      I’ve said for quite a while that any PIA system deployed by manufacturers–even those that are optional–must be developed with enough CPU and internet connection horsepower to be able to respond to verification requests for every drug package they sell. In case of some unforeseen national terrorism event that calls into question every drug package out there, you will find that everyone is checking everything overnight. Your systems have to be able to handle that kind of overnight spike in usage.

      Dirk.

  2. Ray, Dirk,
    Unit scanning in the pharmacy with an auto check back to the manufacturer would be logical check for verification from the initial product source.
    Pharmacies on the other hand are being to their limit on prescriptions processed, checked, and issued in a timely manner. Scanning 2D bar codes for every daily received unit is not currently in the work stream. Jumping to RFID would ease that pain. As I inquired to pharmacists that this may be a good solution to identifying counterfeit meds, the response was the same; Are you nuts? we’re crazy busy now, let alone with another med “check.”
    Establishing an interoperative system is an excellent answer that starts with the manufacturer. Who will be the payor? The electronic and suupply chain solutions are the easy part. Implementation is tricky.
    Amazon, I-tunes, and Departments of Motor vehicles have spent much time and money developing their respective systems. The pharmaceutical supply chain can take the lessons learned and apply them, but the resource investment is still significant.
    Another logical solution would be to employ a non-profit interoperable check system which is funded by all members of the supply chain to spread the costs among the users.
    Geoffrey

    1. Geoffrey,
      Pharmacists may be crazy busy now but if it is found to be necessary that they scan a 2D barcode on every drug package they receive each day in order to protect their patients, then they will just have to make time and do their jobs. If it is not necessary to take that time then they should not be asked to do it. So the question is: Is it necessary?

      RFID is not an acceptable solution for the kind of accuracy necessary. The technology is seeing a big surge in use in the apparel industry, but those use cases provide an ROI even if they are only 80% accurate. You should take notice of RFID for use in the pharma supply chain as soon as you hear that Kohls is allowing customers to pass their shopping cart through a scanner at checkout and letting the customer walk out without someone looking at the contents individually. That would require 99.99% accuracy. That’s the kind of use case and accuracy we would expect for a pharmacy but is not possible with today’s RFID technology and so no one at Kohls or anywhere else is talking about it.

      And besides, pharmacies won’t want to pay for manufacturer’s to put RFID tags on all of their packages. In fact, no one will. RFID won’t make a dent in the pharma supply chain until someone is willing to pay for it. And don’t make the taxpayers pay for it if it isn’t at least 99.99% accurate AND reduces the workload for supply chain companies instead of increasing it.

      Dirk.

  3. This debate all reflects back on the fact that the federal system converted a true “track & trace” system designed by California and watered it down to a “trace-able” system. Until the industry aligns itself by tying payments to scans, i.e. “buying & selling serial numbers” on the packages as the currency of pharmaceuticals trade, we again are designing and implementing a system of trust with the capability of verification instead of PIA at each node of transfer. The notion of each trading “partner” harboring commercial information for fear of being dis-intermediated out of the chain or losing competitive advantage is archaic and leaves us all vulnerable to many trade violations including unauthorized diversion and fraud. A true track & trace system would “clean up” the supply chain resulting in better inventory management for everyone, reduction in expired inventory, improved recall processes, reduction in drug shortages due to better supply/demand balancing, ELIMINATION of costly chargeback reconciliations and reduction of returns errors/fraud. This is just another example of how health care is lagging in adoption of electronic business intelligence systems which could help improve the efficiency and effectiveness of the tasks which deliver safe medicines to our patients. If in fact the US drug supply chain is 99.5% safe, then lets flip the T&T switch and go beyond just being compliant to DQSA and make our supply chains 99.5% efficient as well.

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