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Thursday, 13 March 2014 09:08

Track-and-Trace Law Strengthens Pharmaceutical Supply Chain Featured

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post 84 picIn November of 2013 the president signed into law the Drug Quality and Security Act which many are calling “track-and-trace”. 

Will it affect dentistry?  Maybe.

What is track-and-trace?

The law calls for the FDA to set standards for tracking and tracing pharmaceuticals from manufacturing to dispensing. 

The FDA will do this by requiring the drug manufacturers to create and maintain a transaction history and be able to report, by lot, the movement of their drugs through the supply chain by January, 2015. 

Systems will be put in place to report suspect or illegitimate products by the same date.  It also calls for the serialization of individual products by 2017. 

This means that the bottle given to the patient must have a serial number that ties back to the manufacturing lot, thus end-to-end tracking of the drug.

Why do this?

Over the years there have been a number of occurrences of fake or non-FDA pharmaceuticals entering the supply chain.  In 2012 counterfeit Avastin entered the U.S. supply chain through an act of illegal importation.  A licensed drug wholesale distributor bought Avastin that was labeled for sale in Turkey.  The drug was sold to physicians and small medical clinics around the U.S. 

You may be thinking that the only illegal act was on the part of the wholesaler, but because the product did not have an NDC number or other label features required by the FDA, anyone who bought and dispensed the drug also broke the law.

Pharmaceutical recalls are more common than you may think.  In 2013 there were 60 separate recalls according to the FDA.  Knowing where all of these products are, throughout the supply chain, will provide the avenue to perform a thorough recall.

How will track-and-trace be accomplished?

Manufacturers will create a drug database for their products and require those organizations in their downstream supply chain to interface and update it as products move through their hands.  Each lot sold will have a 2D barcode and a system will be put in place so the scanning of this barcode will update the database at each point along the supply chain.  This will allow the manufacturer to track each lot up to the point of dispensing.

In 2017 they must take it one step further to the actual patient to which the particular drug was sold.

So, why my “maybe” answer to its effect on dentistry?  If you are simply prescribing pharmaceuticals, then you can leave concerns about the track-and-trace law with your local pharmacies and their suppliers.  If you have taken the step to actually dispensing medications from your practice, you will need to participate in the tracking activity.  

Track-and-trace is a right click for consumers and the integrity of the nation’s drug supply.


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