Discounts For PSM Interchange 2011 End Next Week

The Partnership for Safe Medicines has announced that discounted registration to their Interchange 2011 meeting will end on September 15th.  That’s next Thursday.  So if you were thinking about attending, make your decision now and register through this link before the end of next Thursday.  After that the fees will increase.

If you are not familiar with the PSM organization or their Interchange gathering I suggest that Continue reading Discounts For PSM Interchange 2011 End Next Week

California Board of Pharmacy Re-awaken

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.For the first time in over two years the topic of pedigree appears on the agenda of the California Board of Pharmacy for their upcoming meeting on September 7.  Earlier this year in a presentation at the FDA Track & Trace Workshop Board Executive Office Virginia Herald mentioned that the Board would take up the topics of inference, drop shipments, decommissioning and linkage between shipping orders and invoices at a future meeting in 2011.  It’s hard to tell if those will be the actual topics discussed in next week’s meeting because they aren’t called out explicitly.  Here is the item as it actually appears on the agenda: Continue reading California Board of Pharmacy Re-awaken

Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2011

Last year at this time I started an annual estimate of the rise in the percentage of drugs in the U.S. supply chain that will have serial numbers attached.  Click here to read last year’s essay that explains the concept.  It’s not an estimate of the actual percentage today.  Rather, it’s a prediction of the rise from an immeasurably small percentage in early 2010 to 100% at some time in the future.  My plan is to revisit my prediction each year at this time to see how it is faring.  (click the drawing to enlarge it.)

Last year I said I would need to update my prediction if anything in the legal landscape changes.  Nothing has really changed in the last year that would lead me to change my prediction so here is my graph with no changes to the data over last year.  I have simply updated the year and placed an arrow on the X-axis to show the current point in time.

As I pointed out last year, it will be kind of hard to tell how well my prediction is doing if some authority with the means to measure the actual percentage doesn’t step up and make it public.  In the last 12 months no entity has stepped up to Continue reading Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2011

Pew Prescription Project: After Heparin

Last week the Pew Prescription Project, an arm of the Pew Charitable Trust, released a report on the risks of substandard and counterfeit drugs.  This is a meticulously researched report that will likely be used by legislators and regulators to better understand the problems and potential solutions of U.S. pharmaceutical supply chain security.  For this reason it is a must-read for anyone interested in the topics that RxTrace routinely explores.  You can get a copy of the full report PDF, view the associated webcast and graphic here:  After Heparin: Protecting Americans from the Risks of Substandard and Counterfeit Drugs.  I’ll have more to say about the webcast in a subsequent essay.

According to the “Introduction and Background”,

“The U.S. Congress, the U.S. Food and Drug Administration (FDA), the pharmaceutical industry and other organizations have renewed their commitments to remedy existing weaknesses.  This white paper seeks to inform these efforts by presenting a holistic picture of the pharmaceutical supply chain and its problems (illustrated by case studies), and to propose a set of meaningful reforms that will better protect patients.”

The report is 77 pages of text with 24 additional pages of references.  The text is peppered with numbered references for those who want more details on a particular topic.

There are three Chapters.

  1. Pharmaceutical Manufacturing:  Globalization and Quality Management
  2. Barriers to FDA Oversight
  3. Pharmaceutical Distribution

Chapter 1 contains Continue reading Pew Prescription Project: After Heparin

RxTrace: Sophomore Effort

RxTrace just completed its second year of publication. In the last 12 months there have been a total of 28 new essays that attempted to shed light on issues and ideas that fall within the intersection of the pharmaceutical supply chain, track and trace technology, standards and regulator compliance.

Here is the complete list ordered by the total number of hits over the entire year. Continue reading RxTrace: Sophomore Effort

SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach

I recently published an essay on RxTrace called “Plateaus of Pharma Supply Chain Security” in which I proposed that a better timeline for the introduction of technology to secure the U.S. pharmaceutical supply chain was one based on plateaus.  Each succeeding plateau would add the adoption of new technology and/or data communications among the participants in the supply chain with the intent of elevating the security over the previous plateau.

In that essay I included illustrative dates for each of the four plateaus that I offered as an example of the concept, but you could easily imagine the overall program having open-ended dates that would allow the supply chain to adopt one plateau at a time and move to the next plateau only if/when a security problem is discovered at the current plateau.  That is, jump to the next plateau only when necessary.  Taking this approach, you may never actually need to get to the later plateaus.

For example, imagine that the first plateau were for manufacturers to serialize all drugs at the pharmacy-saleable package level (what I normally call “unit-level”) with an FDA Standardized Numeric Identifier (SNI) and all supply chain owners of drugs were to read the SNI’s and simply keep records of who they bought them from and who they sold them to.

With no data communications between trading partners that includes the SNI’s it might seem that little
security has been gained over what is done today.  But this small step (“small” compared to a full pedigree or track & trace system) would allow criminal Continue reading SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach

Illegitimate Drugs In The U.S. Supply Chain: Needle In A Haystack

West-African countries have been under attack by drug counterfeiting criminals for decades with little resistance until the last one.  The result, in 2002 Mohammed Yaro Budah, then president of the Pharmaceutical Society of Nigeria, estimated that 70% of the drugs in Nigeria were fake or substandard.  That’s an incredible figure, but starting around that time the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) under the direction of Professor Dora Akunyili began fighting back.

Initially they focused on inspecting drug imports at the Nigerian ports and airports and they were able to bring the percentage of fake or substandard drugs to come down considerably.  More recently they have begun employing a number of Raman Spectroscopy-based devices called TruScan (recently acquired by Thermo Scientific) to inspect drugs and anti-viral medicines being sold in pharmacies during “unscheduled” visits.

Even more recently, a number of pharma manufacturers have begun to add low cost scratch-off stickers to the drugs sold in Nigeria that cover a random number that can be scratched off and checked for authenticity by patients and healthcare professionals using SMS text message-based technology from Sproxil.  The service was launched in 2010 on a single product but that number is growing quickly as a number of large U.S.-based drug companies add the scratch-off stickers to their productsThe service is sponsored by NAFDAC.

WOULD THESE TECHNOLOGIES WORK IN THE U.S.?

That is, would these technologies help to reduce the number of illegitimate drugs in the U.S. supply chain? I believe that the answer is Continue reading Illegitimate Drugs In The U.S. Supply Chain: Needle In A Haystack

Plateaus of Pharma Supply Chain Security

One of the most recent improvements that California made to their drug pedigree law was to spread out the compliance dates by supply chain segment.   Previously, all segments had to comply with the regulation by January 2011.   Now drug manufacturers will need to comply with half of the products (or sales) by January 2015 and the remainder one year later, distributors must comply by mid-2016 and the pharmacies by mid-2017.   As I understand it, this spread was intended to help the industry fully prepare for the new requirements in their businesses.   Companies would now have time to adjust to the changes implemented by their upstream trading partners according to their earlier deadlines.

This staggered start pleased a lot of people—particularly distributors and pharmacies.   However, to me, the staggered start of the current California regulation doesn’t address the issue of complexity very well and a different kind of ramp up to full operation would be more practical and have better odds for success.

I discussed complexity in my last essay, “U.S. Pharma Supply Chain Complexity”.   I tried to show what it is about the supply chain that leads to difficulty in the setup and execution of a drug pedigree system.   On its own, the U.S. pharma supply chain is naturally complex.   A truly workable and protective pedigree system needs to deal with that natural complexity without exploding in its own complexity and cost.   As I pointed out in that essay, the problem with the more popular pedigree models (like DPMS and the various distributed pedigree models) is the large number of the point-to-point data connections that are necessary to reflect the natural complexity of the supply chain.   That adds a lot of complexity.

THE PLATEAUS OF SECURITY

No matter which model the industry implements, starting it up will have its own complexities.   In my view, regulators and industry should Continue reading Plateaus of Pharma Supply Chain Security

DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.
The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel
and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating
the positions of any company, organization or individual other than Dirk Rodgers.

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