There are lots of mistakes a company can make when designing their solution to comply with pharma serialization and tracing regulations. One of these is to print the unique identifier on the outsert attached to their packaging. An “outsert” is a tightly folded piece of paper that contains very detailed prescribing information intended to inform medical professionals who prescribe, dispense and/or administer the drug. It contains information that the manufacturer must include with each package of a prescription drug, at least in the United States. (Here is an example.)
When drugs are packed within two layers of packaging (known as primary and secondary packaging), this prescribing information is printed on a sheet of paper that can be inserted inside the secondary package (usually a carton), which means it is an “insert”. But when there is no secondary package—such as when drugs are packaged by the manufacturer solely into bottles—the usual way to provide this required prescribing information is on an “outsert”…that tightly folded paper. In this case, outserts are glued to the outside of the bottle, usually the top or the side. That glue is designed to allow the outsert to be removed by the dispensing medical professional in case they need to review things like side effects, dosage and administration information, and lots more.
So far so good. The mistake some companies have made is to assume that this outsert is a good place to print the mandated unique identifier, including the serialized barcode and the human readable data. Usually it is the printer of the prescribing information sheet who offers the drug manufacturer a short cut to meeting the mandate by offering to pre-print the unique identifier on the exposed portion of the outsert. Or, an equipment manufacturer offers a machine that will print the unique identifier on a blank spot on the outsert as it is being stuck onto the bottle. All the drug manufacturer has to do is apply the outsert as normal, then read the barcode that is printed on the outsert. Sounds simple, right? What could go wrong?
THE PROBLEM WITH OUTSERTS
Outserts are a stone age solution to a very real problem. The problem is to provide every medical professional with all of the information they need to safely prescribe, administer and dispense a drug to patients in every possible scenario, including clinical, hospital and emergency. In our modern healthcare system, why don’t we just offer that information on a website…like the one every drug manufacturer already has? In fact, as far as I know, all of the information printed on the outserts is available today right there on the web, in a much more searchable format.
The problem is, the web is not always available. In some parts of the country you can’t get smartphone data service. And in a national or regional emergency (think hurricane, tornado, earthquake, act of terrorism, etc), normal services might not be available over a wide area. In fact, those are precisely the times when extra medical attention is needed and medical professionals might need to administer drugs they are not as familiar with, so they would need to consult the prescribing information sheet that is attached to the drug package…the outsert.
But there is a problem with outserts. Drug manufacturers are required to include the information, but wholesale distributors are apparently not required to ensure the outsert remains on those drug packages through delivery to a pharmacy, hospital or medical office. Outserts are the bane of warehouse operations because they frequently fall off and gum up machines like A-frames and conveyors. They stick to the bottom of your shoes too. They pepper the bottom of delivery totes. They are just not reliable.
Sure, the majority of outserts do make it to the prescribing or administrating destination, but many do not. Now, is that a good place to put a unique identifier? Remember, in a few years, wholesale distributors in the U.S. and the E.U. will not be able to buy or sell drugs that do not have a readable, manufacturer-applied unique identifier on them. And dispensers will not be able to buy drugs that do not have them. For this reason, I would be very surprised if U.S. wholesale distributors will accept drugs that have their DSCSA product identifier (the unique identifier required by the DSCSA, see “The DSCSA Product Identifier On Drug Packages“) printed on the outsert.
Even if wholesale distributors accept them, the FDA should not, because it is too easy to switch the outsert between two packages. Just peel it off of one package and stick it onto another one. Think of the possibilities for criminals. It should not be so easy to remove the unique identifier from a good package and put it onto a bad package.
Think this is a hypothetical possibility? I was contacted by a generic drug manufacturer this week who is thinking about putting the DSCSA unique identifier on their outsert, as proposed by an equipment supplier. Good luck with that. Mistake #1.