DSCSA may sound good but are we really safer?

When discussing supply chain security it is easy to focus on the time between leaving a manufacturer’s door and arrival at the back door of a pharmacy. That is what most view as the supply chain and in many minds it is the most vulnerable time for a drug. Is it?

A lack of original packaging traveling through the pharmacy will mean that DSCSA is truly toothless when it comes to end to end supply chain security.

The antiquated US practice of repackaging of drugs whether in retail pharmacy, in central fill or even mail order pharmacies opens door for the introduction of counterfeits even if DSCSA basically “did its’ job”. When a bulk container arrives at the back door of one of the above listed pharmacies and the serial ID is captured, authenticated, etc. . . DSCSA will look like a success. Once we crack open that bulk container and begin repacking and dispensing all the security of DSCSA is gone. Unfortunately there are too many well documented cases of rogue pharmacists buying from unregulated sources (the internet) and ending up with sub-standard product. It is the exception but it is real. Consider that with unsubstantiated estimates of counterfeit drugs in the US supply chain frequently cited as +\- 1% that we are hopefully talking about the exceptions but with over 4 billion prescriptions per year in the US that 1% is potentially 40,000,000 prescriptions.

Adding to this problem unsuspecting consumers who think they are saving money by purchasing their prescriptions online are more often than not getting counterfeit or at best substandard pharmaceuticals. FDA has published again and again regarding the incredible risk taken by anyone foolish or na?ve enough to buy their pharmaceuticals over the internet. I think close to 95% of FDA’s ongoing sampling shows counterfeit or substandard medications.

So you can see, simply fixing the packaging traveling through the pharmacy is not enough. Even internet traded packaging would need to be original manufacturers packaging AND a massive education campaign teaching the public about the safety of original manufacturer packaging and the ability to scan that bar code for authentication will be the biggest challenge.   

It is achievable. It is not easy. Without this change DSCSA will continue to be toothless. Lots of growl,  no real bite and true safety lost along the way.