Back in 2013, Congress enacted The Drug Quality and Security Act. In this act, The Drug Supply Chain Security Act or DSCSA was born. This legislation was designed to create a mechanism to trace prescription drugs from origin to patient, with each step in between identified. At its core, the DSCSA is about formalizing the product’s pedigree and keeping track of each lot of product from origin to consumption. DSCSA eventually wants to serialize each package the manufacturer ships by assigning each package a unique identifier. This is a worthy goal but like many concepts, the execution is a lot more involved than a simple acronym implies.
Fast forward to 2019. Recently a pharmacist asked me if they could determine which lots of a given drug they received from their wholesaler. The short answer is no, and this was surprising to the pharmacist. DSCSA has been the law of the land for over 5 years now and this is exactly the type of information that it was designed to track! The reason this is still not possible is that this is truly a monumental change. Implementation of DSCSA was planned out over several years, extending into the year 2022. This could be further extended as more logistical hurdles emerge.
As a pharmacist, I tend to think locally. I concentrate on my pharmacy and my patients. The current level of DSCSA implementation is limited to a pedigree record of what I have purchased. Currently, no lot information or other identification is being tracked through the system. Once I receive a product, I can locally document its lot number. I can even document which lots are dispensed to which patients in my pharmacy system, though this is not yet required by DSCSA. When you start to think globally, the real problem starts to emerge.
Data entry becomes a rate-limiting step in DSCSA. In my pharmacy, my employees have to hand-type the lot and expiration into the software in order to track what is leaving the pharmacy. This is time-consuming and prone to errors. Consider what it would take to perform the same level of data logging in a warehouse shipping thousands of orders to pharmacies each day with each order consisting of tens to hundreds of individual manufacturer packages. And that is just for lot and expiration date and does not include any form of serial number. Many of these warehouses are automated so the actual input of information would have to be something a robot could do efficiently.
There are technologies that can handle the serialization and encoding of lot and expiration date available right now. Two-dimensional barcodes can easily be encoded to handle this task and if I had to bet, this is what will eventually be used. The true problem is twofold: 1) developing a standardized coding that every manufacturer uses for its products and 2) placing this information upon each and every product label. Keep in mind that while the government might be able to drive the adoption of a standard coding system, the second option includes caveats like the physical size of individual packages. Some pharmaceuticals, like injectables, have labels that are less than 1 square inch in size!
So DSCSA is far from complete. A lot of work is going on behind the scenes to adopt standardized coding and labeling requirements. With these in place, wholesalers can adopt new processes to consume that information and pass it down to pharmacies, which will, in turn, require pharmacies to adopt new workflows to use the information to complete the life-cycle of the product when it is dispensed to its final destination–the patient.
About the Photo: Winston “Churchill” is an AKC registered Tri-Color Welsh Pembroke Corgi currently living with the this blog’s primary author.