Tag Archives: Pharma Supply Chain

An Open Letter To Blockchain Vendors: Please Pay More Attention

Dear Blockchain Vendors,

It was good to see all of you at last week’s Drug Supply Chain Security Act (DSCSA) and Blockchain proof of concepts pilots review held by the Center For Supply Chain Studies (C4SCS) in Rockville, MD.  I hope your travel home was uneventful.  Let me say right at the top, I was in the audience representing Systech International.  My co-worker, Joe Lipari partnered with Dwight deVere of RxTransparent as the Green Team.  RxTrace is independent of Systech International.  That said, as the author of RxTrace, I have some helpful advice for you. Continue reading An Open Letter To Blockchain Vendors: Please Pay More Attention

Data Ownership In The Track And Trace Cloud, Reprised And Updated

Back in January of 2013 I wrote an important essay called “Data Ownership In The Track And Trace Cloud” which analyzed a potential future where members of the pharma supply chain would need to deposit and maintain track and trace data in a centralized or semi-centralized data repository in the “cloud”.  As the title implies, my main focus was on who would own that data, which was, and continues to be, a hot topic.

But now, five years on, things are getting less “potential” and more real. Continue reading Data Ownership In The Track And Trace Cloud, Reprised And Updated

What’s So Hard About Unique Identifier Verification?

Both, the Drug Supply Chain Security Act (DSCSA) in the US and the Falsified Medicines Directive (FMD) in the EU make use of unique identifier verification in one way or another.  Under the FMD, verification is the centerpiece of patient protection.  Under the DSCSA, verification is used as a tool to help resolve higher risk use cases, like saleable returns to wholesale distributors, and anytime someone becomes “suspicious” about a collection of drug packages.  On the surface, verification of unique identifiers seems simple, but there are some sticky problems that make it complex in some circumstances (see also “Drug Verification: EU Vs US”). Continue reading What’s So Hard About Unique Identifier Verification?

I Receive My First Serialized Drug From My Pharmacy: Is It Right?

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Normally drugs dispensed by American pharmacies are repackaged into the “standard” amber vial.  The pharmacy places their own label on that bottle so the patient normally doesn’t receive the manufacturer’s package that would have the new 2D barcode mandated by the Drug Supply Chain Security Act (DSCSA).  There are a few drugs that are not repackaged by US pharmacies, like most things in an inhaler and drugs in “compliance packaging” like birth control pills.  But even then, the pharmacy puts their label on the package

 

somewhere.

One of the few drugs I take daily is a statin, which has always been put into an amber bottle by my pharmacy.  A few months ago I received a three months supply, and to my surprise, the pharmacy dispensed the prescription in the manufacturer’s original 90-count bottle, and there was the DSCSA 2D barcode on the label.  The pharmacy label was positioned so that it formed a “flag” and did not cover the 2D barcode, and the pharmacy label was easily removed to expose the entire manufacturer’s label.  This drug was made by Lupin Pharmaceuticals, a generic drug manufacturer base in India.  How did they do? Continue reading I Receive My First Serialized Drug From My Pharmacy: Is It Right?

Sponsored: Extracting Value Beyond Compliance From Serialization

Companies are spending hundreds of millions of dollars, euros, rupees and rubles getting ready to comply with serialization regulatory mandates around the world.  Deadlines are fast approaching in the US and the EU and they are already passed in India, South Korea, Argentina and Turkey.  What companies are looking for next is how to extract some value beyond just complying with government mandates.  Just about every solution provider offering serialization components and solutions out there has at least one product or service that is aimed squarely at this type of need.  What we need to do is get these people together:  those who are looking, and those who have the solutions.

Cognizant, a management consulting company, has written a very nice 11-page white paper exploring value beyond compliance. Continue reading Sponsored: Extracting Value Beyond Compliance From Serialization

DSCSA: OIG Report Exposes Likely Enforcement Approach

Last week the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published their second report on the experience of selected members of the pharma supply chain with the exchange of drug product tracing information as required by the DSCSA.  This one was aimed at dispensers.  The one published last fall was aimed at wholesale distributors.  As you know, starting in January 1, 2015 (delayed until May 1, 2015), pharmaceutical wholesale distributors have been required to pass to their customers for non-exempt prescription drug shipments, and retain for six years, transaction documents (TI, TH and TS).  Since July 1, 2015 (delayed until March 1, 2016), dispensers have been required to receive and store these Continue reading DSCSA: OIG Report Exposes Likely Enforcement Approach

The 2 Most Helpful Requirements In The DSCSA

There are lots of impactful requirements in the Drug Supply Chain Security Act (DSCSA), but there are two whose impact will likely increase the safety of patients far more than all of the others.  That is, they are the most helpful requirements.  Do they include serialization?  Verification?  Transaction documentation?  Wholesaler and 3PL licensing?  Not even close.

The two requirements that I believe will have the biggest impact on the safety of drugs in the US supply chain are the requirement to only engage in transactions with authorized trading partners, and the lot number being included in the 2D barcode.  Let me explain. Continue reading The 2 Most Helpful Requirements In The DSCSA

Sponsored: Newly Updated Global Serialization Regulation Map

I just helped IQPC update their printable global pharma serialization regulation map.  Get a copy here.  Things change around the world pretty often so it’s important to update resources like this frequently.  The information for most of the existing countries was updated and I added a few new countries.  It’s a great resource to print and pin up on your office wall, or the company bulletin board to keep everyone focused on the approaching deadlines around the world.  And it looks great too! Continue reading Sponsored: Newly Updated Global Serialization Regulation Map