The Coming Battle Over Decommissioning At The Pharmacy

The U.S. pharma supply chain will operate under two major phases as dictated by the Drug Supply Chain Security Act (DSCSA).  We are now operating under the first major phase.  Well, OK, it won’t be fully operational until July 1st when dispensers (see “Who Is A DSCSA Dispenser?”) are required to begin receiving, saving and

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3 thoughts on “The Coming Battle Over Decommissioning At The Pharmacy”

  1. If the death certificate is issued at receiving at the pharmacy, IMO, that would be the good balance between patient safety and the viability of this plan. However, I say let the large distribution companies take on the responsibility, NOT the pharmacy. The package of medication was received at the pharmacy? have the distributor and their carriers keep those records as part of the supply chain. Again, NOT the pharmacy.

    To have the pharmacy issue a death certificate at the time of dispensing, even though simple in theory, is quite complicated. Each additional regulation placed upon pharmacy compounds the issues of receiving a medication in a timely manner. The end results of a poorly placed regulation hampers the effectiveness of the pharmacy to serve the patients. Instead of concentrating on visiting with the patient and doing correct counseling, the increased regulations forces the pharmacist to cut corners in order to fulfill requirements of the new regulations and dispensing the medication in a timely manner.

    Try working in a pharmacy where there are hundreds of prescriptions dispensed per day. Pharmacy is the number one regulated industry. Keeping track of every law, regulation, statute, etc is getting to me almost impossible for the pharmacist. Pharmacists are not lawyers. Let them be pharmacists and help patients.

    1. By large distribution companies, I presume you mean ABC, Cardinal, and McKesson. What though if there is an intermediary before the product reaches the pharmacy? It could also be shipped to a retail pharmacy distribution center as well.

      The pharmacy then takes custody, but what then would stop the pharmacy from sending that material, a bottle for instance, back to its own central distribution center or moving it to another pharmacy if there was need, or in a hospital setting, to another outlet even in the health system, that could be in the same building. I ask because I don’t typically operate at this level so I don’t know.

      I haven’t worked as a pharmacist, but I can understand the complexity, especially working with unit dosage and here, especially from a data management perspective.

      The wholesalers are already operating this capability and technology in places to help support processing the receipt and management, I expect they would be more than willing to provide the service of decommissioning, at a pharmacy level if so contracted.

      The last step in the process however, is where product could also be likely to be diverted or non-genuine product still could run the risk of being introduced, so I see this step as being just as critical, potentially more from a patient interaction standpoint, than any other.

      1. Ryan,
        Thanks for your comment. The points you have raised with your questions are exactly why it is a bad idea for a wholesale distributor to preform the decommissioning step on behalf of their pharmacy clients, in most cases. On the other hand, if a pharmacy knows they will not engage in exchanges with other pharmacies, or returns, they could potentially contract with their supplier to perform the decommissioning step upon shipment of the drugs to that pharmacy. I’m not sure the FDA would consider that an acceptable time to perform the decommissioning, so this would be subject to their agreement in the future. Until the FDA provides guidance on decommissioning (if they even expect it) we won’t know what is acceptable.

        Dirk.

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