The U.S. Senate Health, Education, Labor and Pensions (HELP) Committee released a new discussion draft last Friday of a bill that would preempt all state pharmaceutical ePedigree laws and establish a pathway toward a nationwide track & trace regulation. Take careful note of this one. It could be the one that finally makes it. Let me explain. Continue reading The New Pharma Track & Trace Discussion Draft In The Senate
Tag Archives: track and trace
The New GS1 Healthcare US Track & Trace Guidance
GS1 Healthcare US, an arm of GS1 US the member organization (MO) of the global GS1 standards organization, has just published the “preliminary version” of a track & trace implementation guide. The full title is “Implementation Guideline, Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes To Support Pedigree And Track & Trace, Release 1.0”.
This document contains the accumulation of thought and best practices generated over the last nine years within various working groups of GS1 Healthcare US and from pilots conducted by its members (including the Abbott Labs, McKesson, VA and GHX pilot that I wrote about in “The Significance of the Abbott, McKesson and VA Pilot”). Pulling it all together into a single coherent document turned out to Continue reading The New GS1 Healthcare US Track & Trace Guidance
Well-Intended Report Calls For Global Track & Trace Of Pharmaceuticals
I’ve been reading the Institute of Medicine (IOM) report called “Countering the Problem of Falsified and Substandard Drugs” that was published last week. At 360 pages, it is quite literally a book, and you can buy it that way. But they also allow you to download the “Pre-publication Copy: Uncorrected Proofs” version in a 300 page PDF for free. I’m not sure why they would post uncorrected proofs rather than the final document on their site but I assume the text is in its final edited form and only the formatting might be different between the book and the PDF. I hope so anyway.
I have not yet read the whole thing so this isn’t intended to be a proper review (see the Regulatory Focus article about it). The document offers Continue reading Well-Intended Report Calls For Global Track & Trace Of Pharmaceuticals
InBrief: Pharma Supply Chain Community Calls For Solutions To Security Problems
At their 100th annual meeting this week, the National Conference of Pharmaceutical Organizations (NCPO) resolved that their member organizations will work together to help further secure the pharmaceutical supply chain. The 101 year old organization is composed of major pharmaceutical industry associations from each primary segment:
American Association of Colleges of Pharmacy
American Pharmacists Association
American Society of Health-System Pharmacists
Biotechnology Industry Organization
Consumer Healthcare Products Association
Generic Pharmaceutical Association
Healthcare Distribution and Management Association
National Association of Boards of Pharmacy
National Association of Chain Drug Stores
National Community Pharmacists Association
Pharmaceutical Research and Manufacturers of America
In a background document attached to a press release, the three Continue reading InBrief: Pharma Supply Chain Community Calls For Solutions To Security Problems
InBrief: FDA Again Says It Plans To Publish Track & Trace Guidance By Year End
Many thanks to Alec Gaffney of Regulatory Focus for pointing out that the FDA just published their annual list of draft guidances that they anticipate will be published before the end of 2013. Of course, no guarantees come with it. In fact, they included the anticipation of Track & Trace guidance in last year’s list as well but nothing was published (See “FDA To Publish Track & Trace Standard By Year End“). That’s why it’s not surprising that it’s on the list again this year.
The FDA list seems to come out earlier each year. Considering that the Track & Trace guidance was included on last year’s list, perhaps it will be published in the near future. I’m not holding my breath, but it sure would be an interesting addition to the current situation in California where Continue reading InBrief: FDA Again Says It Plans To Publish Track & Trace Guidance By Year End
How Should Inference Work?
The wide-scale use of “inference” in the pharmaceutical supply chain is essential to the successful operation of a track & track or ePedigree system. Companies cannot be expected to open every case they plan to ship, or that they receive, so that they can figure out exactly which package-level serial numbers are involved. The use of the serial number packaging hierarchy, or, “Aggregation information”, to “infer” which packages are being shipped or received is the only way to maintain a level of supply chain efficiency that is close to pre-serialization levels. On the other hand, regulator acceptance of the use of inference in the supply chain has the potential to complicate their investigation of criminals.
In recognition of its importance in maintaining efficiencies, the California legislature instructed the Board of Pharmacy to draw up rules that would allow companies to optionally make use of it (see my essay “Inference in the Pharmaceutical Supply Chain” for the exact text of the inference provisions of the California Business and Professions Code). It leaves the important question about who Continue reading How Should Inference Work?
Data Ownership In The Track & Trace Cloud
Who will own the data that supply chain trading partners store in some future cloud-based, semi-centralized Network Centric ePedigree (NCeP) data repository? I met one potential future repository service provider who seemed to think that they would own that data. Imagine their excitement. All the data about where drugs go throughout the supply chain! Think of the value they could mine from that.
Well, that’s never going to happen because companies in the supply chain won’t sign up for handing over all of their supply chain data to some third-party just so they can comply with regulations, especially when there exists an alternative approach that would allow them to avoid using a third-party and still comply (by using DPMS). And regulatory agencies are Continue reading Data Ownership In The Track & Trace Cloud
Pharma Anti-Counterfeiting and Serialization
Counterfeiting of drugs has become a favorite activity of organized criminals and it negatively impacts the citizens of every country in the world. The pharma industry is multi-national, the criminals are multi-national, the patients that are harmed are multi-national. What we need now more than ever before is a multi-national approach to fighting these crimes.
That’s why I was deeply disappointed last week to read that the World Health Organization (WHO) has barred a group of people with certain global crime fighting ideas from participating in their “member state” meeting on substandard/spurious/falsely-labelled/falsified/counterfeit medical products being held today through Wednesday in Buenos Aires, Argentina. See the Reuters article “Row flares over global fight against fake medicine” and see Roger Bate’s introduction to the group’s position “How to achieve international action on falsified and substandard medicines” and don’t miss the full PDF containing the group’s well-stated position.
The dispute is Continue reading Pharma Anti-Counterfeiting and Serialization
