The healthcare, life sciences and pharmaceutical sectors face a lot of challenges in their manufacturing, operations and supply chain management processes. The US Food and Drugs Administration insist that companies implement track and trace systems to improve the security of prescription drugs to customers. Counterfeit drugs are major problem and accounted for $75 billion in revenue in 2010 according to the National Association of Boards of Pharmacy. Implementing electronic track and trace for prescription drugs with serialization will reduce the counterfeit products over a period of time.
Serialization or Unique identification helps us to identify who manufactured the product, which wholesaler has sold to retailers or hospitals and to which customer it has been prescribed. The implementation of serialization and track and trace provides the ability to track and trace the lifecycle of the drugs in the system end-to-end. The US Food and Drugs Administration sets some standards to ensure safe manufacturing and distribution of prescription drugs. The US Food and Drug Administration requires an e-pedigree electronic document which documents the full history of particular or entire batches that are manufactured and then prescribed to patients. The e-pedigree helps to prevent the prescription drug from being misbranded, sold after expiry, counterfeited, diverted, stolen and/or contaminated. All manufacturers, wholesalers, repackagers, OEM’s and pharmacies must comply with the e-pedigree requirements and submit prescription drug information, source and destination, how and when it was prescribed to a customer, to the e-pedigree system.
How does a track and trace system improve security?
A track and trace system improves security by:
Knowing the life cycle of the prescription drug, from where it is manufactured, who is repackaging it, who is distributing, when it is prescribed and when it is sold
Meeting accurate regulatory and compliance requirement questions such as “What, Where, When and Who”
Locating prescription drug batches and precisely where they are distributed
Enabling the option to recall a particular batch or entire batches which are reported as having a product/batch failure or having not met standards
Identify if the prescribed drug is counterfeit, stolen, contaminated etc.
Know about the multi-container packaging item level details
How does track and trace work?
Track and trace works in the following ways:
Generate and apply unique serialization number for manufactured drugs.
Capture unique serialization number and store in centralized database (distributed or non-distributed).
Update serialization data in EPCIS centralized database.
Wholesalers, Repackagers and Pharmacies can have the ability to validate the serialization when they perform transactions.
Each time a transaction for serialized drugs is carried out, the transaction drug history is updated in the e-pedigree system.
What is EPCIS (Electronic Product Code Information Services?
EPCIS is a GS1 standard that enables companies to capture, update and share information about the products end-to-end in the supply chain life cycle.
The following links provide details of different manufacturers of track and trace and serialization software