Friday, June 10, 2022

If You Own A Pharmacy You Need To Know About The DSCSA.

Pharmacists are the guardians of medications.  You know what they do, how they interact with one another and can often help prescribers find the best one for your patients.   But there is one other, perhaps even more critical thing, pharmacists need to do to make sure people get, take and actually benefit from the medications their doctor prescribed; is the medication in the bottle on your shelf actually real?  

That's what DSCSA is all about.  The acronym stands for Drug Supply Chain Security Act and its core purpose is to designate ways pharmacists can be sure the medications they dispense are real.  Counterfeiting of drugs is a real issue and the counterfeiters have become expert at finding ways to place their fake drugs into the supply chain.  That's where DSCSA comes into play.  

Passed nearly 10 years ago the regulations, up to this point, have affected mostly manufactures and distributors.  They have had to develop, with the help of industry standards and trade organizations, ways to authenticate and trace prescription medications in the supply chain.  The results of this have been most visible to retail pharmacies as the pedigree documents that come with your orders.  

While much of that "up stream" work has been done and the pressure is now on retail pharmacy to develop policies, tools and systems to assure that the products they purchase are in compliance with the new regulations.  And with more and more pharmacies utilizing secondary suppliers this process is becoming more important
and more complicated. 

I just did a podcast with two experts who talk about what this means to retail pharmacies.  It runs for about 40 minutes and includes comments from Perry Fri, EVP of the Healthcare Distribution Alliance and Leon Nevers, Director of Procurement for HEB, a world class grocery chain with pharmacies in Texas.  

You can listen to the podcast using this link:  

https://traffic.megaphone.fm/CSN2107439901.mp3?updated=1654533358

The BIG takeaway is that your primary wholesaler can help with this but you shouldn't count of them to provide you with all the tools you need.  And, the time to get started in now!  You can do that by talking with your wholesaler rep. to see what he/she can tell you and by accessing some documents prepared by the Healthcare Distribution Alliance at:  www.HDA.org/issues.

Here's hoping this information helps you prepare for the policies and procedures you'll need to put in place to meet the regulations which go into effect - with penalties - in Nov. 2023.  

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