Serialization's Role In Patient Safety
Updated: Aug 6, 2019
As most readers will know, one of the key rationales for numerous global governments creating their serialization regulations was to fight counterfeits which had been implicated in millions of patient deaths globally.
Sadly though, as these regulations take hold and we start to see results - Europe, even though they are not tracing product, have already found 100's of falsified packs in multiple countries and of multiple drugs.
So, it's working, right? Well not really!
Just this week I was involved in what must be my 1,000th discussion of what is a saleable unit? There are plenty of examples in all countries where the patients interest is not really being placed first. Simplicity and doing the bare minimum to meet the regulation sadly seems to be the order of the day for many.
For the patient to be truly protected, we need to see regulations clearly dictate that the lowest level for serialization is equivalent to either the item that is handed directly to a patient in a pharmacy (or hospital) or, the bulk item which a hospital can make a unit dose out of. Only when we see this, will every Carton or Bottle be verifiable and thus, the patients can start to feel truly cared for by the pharmaceutical supply chain.
In hospitals and those organisations that hospitals contract to produce HUD (Hospital Unit Dose) packs, they need to ensure that the serial number (and GTIN) from the master pack is replicated down to each HUD item, be that a vial, syringe, bottle or blister. As long as these HUD items are labelled, it will be possible to verify at the bedside, that not only is the patient getting the right dose of the right drug, but that the drug is actually what it says it is.
I walk through many foyer of pharma companies and all have clear messages about their desire to help their patients. Only by thinking about the finite detail in the supply chain and helping the patient by ensuring that those companies handling the drugs are following some simple housekeeping rules, can this actually become a reality.
For USA and DSCSA, 2023 - I firmly believe that this needs to be the level of detail that the FDA needs to regulate. If not, we will continue to see 100's if not millions of deaths worldwide from falsified medicine and the Billions of $ spent on Serialized Infrastructure will be for nought.
If you are concerned about your supply chain and wish to discuss how to ensure that your patients are truly receiving only what you make for them, please give Xyntek a call. One of our dedicated healthcare professionals can work with you to make you drugs as safe as possible.
Senior Director, Global Management & IS Consulting