There are lots of impactful requirements in the Drug Supply Chain Security Act (DSCSA), but there are two whose impact will likely increase the safety of patients far more than all of the others. That is, they are the most helpful requirements. Do they include serialization? Verification? Transaction documentation? Wholesaler and 3PL licensing? Not even close.
The two requirements that I believe will have the biggest impact on the safety of drugs in the US supply chain are the requirement to only engage in transactions with authorized trading partners, and the lot number being included in the 2D barcode. Let me explain.
ONLY ENGAGE IN TRANSACTIONS WITH AUTHORIZED TRADING PARTNERS
These provisions—one for each segment, including manufacturers, wholesale distributors, repackagers and dispensers—all went into effect on January 1, 2015. Prior to that date, there were no federal laws preventing companies in the supply chain from buying drugs from unlicensed parties.
The Prescription Drug Marketing Act of 1987 (PDMA) established a pedigree requirement for any drug that was distributed by anyone who was not an authorized distributor of record (ADR), but the regulations related to that law were repeatedly delayed until 2006. A few days after they went into effect in that year, a small wholesaler filed suit in federal court and the judge stayed some of the provisions until an agreement in 2011 led the FDA to eliminate them entirely (see “Impact of RxUSA v. HHS On Future Pedigree Legislation“).
In fact, even when “pedigrees” were required—either voluntarily or by state law—by companies in the supply chain from suppliers who were not ADRs, things didn’t always go so well, as documented by Katherine Eban in her 2006 book “Dangerous Doses” (see “Dangerous Doses”). It wasn’t until just after her book was published that the “big 3” wholesale distributors promised to buy 100% of their supplies only from the original manufacturer. I contend that that promise is what put an abrupt end to the kind of sad episodes that Ms. Eban included in her book (see “Do We Even Need To Mandate Drug Pedigrees Anymore?”).
The DSCSA does not require wholesale distributors to only buy directly from the manufacturer, but it makes it a little harder if they don’t (see “DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 2”). The provisions that force everyone in the supply chain to only engage in transactions with authorized trading partners makes it a federal crime to trade with anyone who doesn’t have a state or federal license. This has led companies to keep tighter track of their suppliers licenses and their expiration dates. In my view, these provisions will keep companies focused on buying only from legitimate sources, which results in a “closed” distribution network, reinforcing perhaps the most important firewalls against the introduction of counterfeit drugs (see “The Built-in Protections Of The U.S. Pharma Supply Chain”).
THE LOT NUMBER IN THE 2D BARCODE
The other most helpful requirement in the DSCSA is the requirement for the lot number of the drug to be included in the 2D barcode. This was originally required by November 27, 2017 but the FDA announced last year that they would not enforce it until November 27 of 2018. Requiring the lot number in the 2D barcode means that, for the first time, the lot number will be machine readable on all drugs. This will have a profound effect on how fast and how tightly recalls are handled in the US.
According to the California Board of Pharmacy, when shortages of Heparin occurred as the result of the massive Heparin adulteration recall back in 2008, some of the recalled units were returned to wholesale distributors as part of the recall, only to be shipped back to hospitals the next day (see “We Should Be Ashamed Of The U.S. Approach To Pharma Recalls”). The slow end to that sad episode can be attributed almost exclusively to the fact that reading the lot number and detecting recalled items could not be automated. With so many lot numbers (but not all of them) in recall, humans became overwhelmed.
Once most drugs in the supply chain have the DSCSA 2D barcode on them, the lot number will be machine readable. From that point on, the removal of recalled units can be automated. Great, right? Well, the problem is, nothing in the DSCSA requires parties in the supply chain to make use of the machine readable lot number to monitor for recalled lots. I’m hoping that companies voluntarily implement software that will routinely and automatically check every unit or case scanned against recall lists so that the Heparin experience will not reoccur. I’m confident that will eventually happen across the supply chain, but maybe not overnight, since it is not mandated. Someday, when that functionality becomes widespread, the safety of the supply chain—especially in a large-scale, life threatening recall like Heparin was in 2008—will increase significantly.
WHAT ABOUT SERIALIZATION?
Those are the two most helpful requirements found in the DSCSA. Do you know of any other provisions that are as helpful as those? Some people may think that the serialization requirement qualifies for this list. I disagree.
I believe that the actual incidents of illegitimate drugs passing through today’s US pharma supply chain is so small that serialization will not have much impact on the miniscule percentage that remain. I suspect that percentage is much smaller than the percent of errors that will naturally and innocently occur in the supply chain. If I’m right, it means that the noise caused by these innocent serialization-induced errors could actually mask the few illegitimate drug events rather than expose them (see “Illegitimate Drugs In The U.S. Supply Chain: Needle In A Haystack”). That’s a reflection of just how clean our existing pharma supply chain is here in the US.
As I’ve said before, I wish someone had studied the problem before leaping to design the solution mandated in the DSCSA (see “What are Pedigree Laws Trying to Accomplish Anyway?”). I believe that study would have resulted in:
- Surprise and pride in just how secure our pharma supply chain really is already;
- Identification of what it is that actually leads to the few instances of illegitimate drugs in our supply chain;
- Better decisions on exactly how to block those specific things without negatively impacting the efficiency/cost of supply chain operations;
- An even safer and lower cost supply chain.
Absent that study, we were handed the DSCSA. At least now we can choose to automate the detection and handling of recalls!