Posts Tagged ‘serialization’

Linear barcodes have served us well for almost half a century, but NOW is the time to move on to something else in the global pharmaceutical supply chain.  I think most people already agree with that but I’m not sure everyone fully appreciates exactly why that is.  It’s important to fully understand the reason why so that your resolution to move away from linear barcodes is strong and you won’t drag your feet or look back.  So let me show you.

                      SERIALIZATION
THE DAWN OF ^ CIVILIZATION

No matter what you might think is going to happen to ePedigree or track & trace regulations going forward, more and more governments around the world are concluding that legitimate pharmaceuticals should come with unique identifiers—serial numbers—attached to them by the manufacturers and repackagers.

Serialization is upon us and I believe that in 10 years the ongoing benefits from it around the globe will significantly exceed the ongoing costs.  Whether you agree to the benefits or not you certainly must accede to the fact that Read the rest of this entry »

The California ePedigree law goes into effect for manufacturers in 2015/2016.  In mid-2016 distributors and repackagers will need to comply.  The California pedigree law includes the need for manufacturers and repackagers to serialize drugs at the smallest level of distribution to pharmacies.  That’s just one of the requirements, they also need to make reference to those serial numbers in the ePedigrees that they create (manufacturers) or update (repackagers, distributors and pharmacies).  (For more on the full pedigree regulation see my essays “The California Pedigree Law” and “California Pedigree Law:  Historic Change To Commerce”).  The implications of this to repackagers are unique.  Let’s explore why. Read the rest of this entry »

The U.S. Food and Drug Administration (FDA) published their “Standardized Numerical Identification (SNI) for Prescription Drug Packages – Final Guidance” document almost two years ago (see my essay “FDA Aligns with GS1 SGTIN For SNDC” from back then).  The guidance was published as purely non-binding recommendations that reflected the Agency’s current thinking, but in my opinion it is a nice piece of work and can be used as a practical guide, as far as it goes, for implementing drug serialization programs today.

Why is that?  It’s because drug manufacturers and repackagers need to serialize all of their prescription drugs that enter the state of California in 2015/2016.  Can those companies make use of the FDA’s SNI guidance to comply with the serialization requirements of the California Pedigree Law?  I will answer that question in this essay, but first Read the rest of this entry »

In a long awaited and much anticipated move the Healthcare Distribution Management Association (HDMA) published updated guidance for the formatting, encoding and placement of barcodes in the U.S. pharmaceutical supply chain.  The document is called “HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain 2011”.  The guidance is aimed mostly at pharma manufacturers and repackagers who place barcodes on their drug packages, cases and pallets.  The last time the guide was published was in 2005 and this new edition includes some significant changes that everyone in the supply chain who deals with product and shipping container labeling should be aware of.

The updated document can be downloaded from the HDMA Marketplace web page.  It is free to HDMA members.  Non-members will need to pay a fee but don’t let that stop you from downloading a copy if you have any Read the rest of this entry »

In the U.S. pharmaceutical supply chain this question becomes, should regulators—state legislatures, state Boards of Pharmacies, Congress or the FDA—mandate specific technology for serialization, ePedigree and other regulations?  This question arises whenever a new regulation is considered by any of these bodies or agencies.  It’s an important question now that the FDA is considering standards for ePedigree, Track & Trace and related things and I think there are some natural conclusions that can be drawn from past examples that lead to a potential answer.  Let’s review the history first.

EXAMPLE:  EXISTING ePEDIGREE LAWS

The language of the U.S. Prescription Drug Marketing Act (PDMA) specified the kind of data that must be in a compliant pedigree but it did not identify any particular technology to carry that information.  Of course, compared with today, what kind of technology was available back in 1987 when the PDMA was first introduced in the U.S. House of Representatives?  Is it a paper pedigree?  Can it be electronic?  What is the format?  Can GS1’s Drug Pedigree Messaging Standard (DPMS) be used to comply? Read the rest of this entry »

Earlier this summer J. Wiley & Sons published a new book called “Pharmaceutical Anti-Counterfeiting, Combating the Real Danger from Fake Drugs” by Mark Davison, CEO of Blue Sphere Health, a pharmaceutical consultancy.  I pre-ordered it on Amazon.com in the spring and it was finally delivered in July.  You may have noticed the image and link I added to the left margin under “RxTrace Recommends” shortly after I started reading it.  The hardbound book is 400 pages, including the main text, notes, references, glossary and index, but it took me until now to finish reading it.  I’ve been so busy lately that I could only read a few pages at a time, that is until my vacation when I finally had time to sit down and read the whole book.

The book is broken up into five parts.  Part 1, General Themes, provides an in-depth examination of the problem of drug counterfeiting around the world including its formal definition, the origins, costs, risks, and the contrast (and controversy) between intellectual property and anti-counterfeiting.  In the last chapter of Part 1, Davison explains the difference between “Traceability” and “Authentication”.  He points out that the term “Traceability” is sometimes known as “digital authentication”, where the term “Authentication” by itself is usually used to Read the rest of this entry »