Tag Archives: pharmaceutical supply chain

Drug recalls

We Should Be Ashamed Of The U.S. Approach To Pharma Recalls

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Flicker / Akulawolf

That’s right.  We should all be ashamed of the way our supply chain handles drug recalls and we should do something about it.  I will explain, but first, what is a drug recall?

Today, when the manufacturer decides that a recall is necessary—either on their own or through a request by the FDA—they issue a recall for it.  The FDA website is a great resource for learning about what a recall is (see “What is a recall?”, and “FDA 101: Product Recalls – From First Alert to Effectiveness Checks” and their recalls homepage at “Drug Recalls”).

Recalls can be issued for a number of reasons including Continue reading We Should Be Ashamed Of The U.S. Approach To Pharma Recalls →

crimes

InBrief: Pharma Supply Chain Criminals Get Justice

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Two weeks ago, confessed pharma supply chain criminal William Rodriguez of South Florida was sentenced to 10 years of prison time, and then two years of supervised release.  He was also required to hand over $55 million, which represents the proceeds from his crimes.

What was his crime?  He was the person who ran the licensed wholesale drug distribution company formerly in South Carolina, Ocean Pharmed, that bought the Novo Nordisk insulin that was stolen in a cargo theft back in 2009.  In his plea, Rodriguez admitted that all of the drugs that Ocean had sold into the supply chain had been obtained from unlicensed or otherwise illegitimate sources, like the stolen insulin.

This is the story that was so well documented by Katherine Eban in her excellent March 2011 article, “Drug Theft Goes Big” in Fortune Magazine online, and which I discussed in my essay “Lessons from ‘Drug Theft Goes Big’” and further Continue reading InBrief: Pharma Supply Chain Criminals Get Justice →

UDI

FDA Proposed UDI: A Revolution In Number Assignment

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Like so many others, I had been patiently awaiting the publication of the U.S. Food and Drug Administration’s (FDA’s) Unique Device Identification (UDI) proposed rules.  Now that they are out I’ve been studying them and I think I will have enough to say about them that I will cover the topic in a multi-part series.  Today I want to look at just one of the differences between the FDA’s proposed UDI rule for medical devices and their National Drug Code (NDC), the pharmaceutical unique identifier.  The NDC structure was first conceived by the FDA back in 1969.  For more about the history of the NDC see my essay “Anatomy Of The National Drug Code”.

The thing I find fascinating is that at the same time they created the NDC for drugs back in 1969 they also created a comparable identifier for medical devices.  They called it the National Health Related Item Code (NHRIC).  Both the NDC and the NHRIC were voluntary until 1972 when the FDA made Continue reading FDA Proposed UDI: A Revolution In Number Assignment →

HDMA

Standards and Guidance For U.S. Pharma Supply Chain Technology

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[This essay is one of two long lost essays that have now been restored on RxTrace.  It was originally published on November 22, 2010.  See “Return Of Two Classics” for an explanation.]

In my last essay, “Who Will Decide Which Pedigree Model You Will Invest In?” I pointed out how easy it is to get confused about pedigree technology because of varying claims made by certain companies who have interests that don’t align well with yours.  So where can you get better information?  I can provide you with a few good sources, and I will also tell you about a missing ingredient that I see in the current guidance landscape that will need to be addressed in the next couple of years. Continue reading Standards and Guidance For U.S. Pharma Supply Chain Technology →

serialization

InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2012

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Click image to enlarge

In August 2010 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 my first essay on the topic which explains the concept.  Click here to read my 2011 essay.  These are not estimates of the actual percentage today.  Rather, it is 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 Continue reading InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2012 →

California Pedigree Law

Who Will Decide Which Pedigree Model You Will Invest In?

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[This essay is one of two long lost essays that have now been restored on RxTrace.  It was originally published on November 15, 2010.  See “Return Of Two Classics” for an explanation.]

In one of my most widely read essays, “RFID is DEAD…At Unit-Level in Pharma”, I pointed out that the choice of serial number carrier technology to be used for compliance with the California Pedigree Law would be decided solely by the pharmaceutical manufacturers.  I pointed out that most of them would end up choosing 2D barcodes because their ongoing costs for Radio Frequency IDentification (RFID) would be too high.

Since the law doesn’t specify a carrier technology, and because the manufacturers will foot the bill for whatever technology is used, naturally, they get to lead the supply chain in that choice.  If you don’t like what they are choosing, then please, step up and pay them to put your preferred carrier technology on their packages.  I’m sure the manufacturer’s would put whatever you want to pay for on their packages as long as it would comply with the law.

But what about the pedigree model that the supply chain will use for compliance?  Can we apply similar logic to determine who will get to choose the technology that defines what a compliant pedigree is?  Yes we can!  And here it is. Continue reading Who Will Decide Which Pedigree Model You Will Invest In? →

California Pedigree Law

PDUFA Will Not Include RxTEC

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Politico.com reported today that the national track and trace addendum that many hoped would be made part of the Prescription Drug User Fee Act (PDUFA) of 2012 was rejected by the U.S. House and Senate Conference Committee.  That committee is working on merging the differences between the versions adopted by the two Houses of Congress into a single bill.  See “’Track And Trace’ On Ice For Now” in Politico PULSE.

According to Politico, “The word emerged late Sunday night from congressional staffers working on the package who said a last-minute compromise effort failed to win the support of stakeholders, and a decision had been made to drop it — for now.”

Assuming there isn’t a last minute reconsideration, this means that the odds are now slim that a national regulation will preempt the California pedigree law before its effective dates.  The remaining chance comes from the fact that the industry is well organized and well represented by the Pharmaceutical Distribution Security Alliance (PDSA) and could decide to back the introduction of a stand-alone bill that contains the essence of the Pharmaceutical Traceability Enhancement Code (RxTEC) language that was part of the PDUFA negotiations, or some other proposal.  The success of such an approach likely depends on Continue reading PDUFA Will Not Include RxTEC →

Counterfeit Drugs, Reimportation

Some People Actually WANT To Buy Counterfeit Drugs

It’s hard to imagine why people would actually prefer to buy drugs from internet websites that are obviously not licensed legitimate pharmacies.  That is, those that do not require proof of a valid prescription from a legitimate prescriber, and/or do not carry an online pharmacy certification (especially from the National Association of Boards of Pharmacy, NAPB, VIIPS program).  In an earlier essay I said this about people who would buy drugs from these illegitimate sources:

“Most of the criminal activity has moved out of the legitimate supply chain, mostly onto the internet.  You know, the internet, where criminals can sell drugs directly to the few consumers who are dumb enough to think that someone will sell them legitimate prescription drugs, but do so illegally by not requiring a prescription.  That is, they think that some faceless company would be willing to knowingly break one law, but could then be trusted to provide real pharmaceuticals at below market prices.  In the age of the internet, how do you protect people who are that gullible?”

A few weeks after writing that rather disparaging passage I met one of those gullible people Continue reading Some People Actually WANT To Buy Counterfeit Drugs →