Are you DSCSA compliant?
A business axiom called the 80/20 rule or the Pareto Principle, says that 80% of your problems will be generated from 20% of the transactions. When analyzing the problem of drug supply chain security, that ratio is probably closer to 90 to 10. About 90% of the time, the transaction information for DSCSA reporting will be incredibly boring: this drug manufacturer made the drug on this date, a wholesaler received it on this date and it was shipped to us on this date.
Congratulations! You’ve just complied with the DSCSA.
But 10% of the time there will be significant issues:
- It’s simple accountability. Was the product and lot number in question even received into your system?
- Does your facility repackage a large quantity of medication into smaller doses? Sometimes full cases of individual products don’t end up in one final destination. They get repackaged or reworked into other totes and sent to other facilities.
- Was there an event at the facility that caused a transfer of drug product from one site to another? Was the transfer properly accounted for and communicated internally?
- Was there a shortage that caused a circumvention of the standard process and made it necessary to manually transact a supply chain event?