I was on an industry call a few weeks ago when someone from a technology vendor suggested that the industry should take some particular action because, it was aligned with “the spirit of the Drug Supply Chain Security Act (DSCSA)”. That got me to thinking… Continue reading Does the DSCSA Have A ‘Spirit’
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
The 2014 Partnership for Safe Medicines (PSM) Interchange event was held on September 18 in Washington DC. This was the fifth year of the event and every year it gets better. That’s why RxTrace has been a media sponsor of the event for the last four years. This year, I found every speaker to be compelling. Next year I am elevating this event to my “highly recommended” short list.
Attendance at the event has grown each year and this time they reached the capacity of the venue and were forced to cut off registrations some time before the day of the event. A number of RxTrace readers were present at the this year’s event but more ought to attend going forward.
The PSM interchange is a different kind of event. It’s not a “how to” event. Over the years, the speaker lineup has included State and Federal pharma regulators, criminal justice professionals (investigators and prosecutors), academics, politicians, pharmaceutical industry associations, medical professionals and occasionally, victims of counterfeit drugs. The audience includes all of the above, plus Continue reading The Partnership For Safe Medicines Interchange 2014
The Partnership for Safe Medicines (PSM) announced recently that Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), will be the keynote speaker at their annual Interchange event next Thursday, October 24, 2013 at the Newseum in Washington DC. RxTrace is a media partner for the event again this year and I plan to attend.
According to the PSM website:
“The annual Interchange brings together policymakers, pharmaceutical manufacturers, patient advocates, law enforcement, healthcare professionals, and anti-counterfeiting companies to discuss the problem and solutions to the global scourge of pharmaceutical counterfeiting.”
There are a number of important misunderstandings out there related to exactly how illegitimate pharmaceuticals get into the hands of unsuspecting consumers and patients. We need to understand all there is to know about the subject, especially those who are responsible for protecting the public against criminal activity and those who are contemplating new laws aimed at elevating the integrity of the supply chain. In this post, I want to define and differentiate the legitimate and the illegitimate pharmaceutical supply chains.
- Accordant with law or with established legal forms and requirements; lawful
- Conforming to known principles, or accepted rules; valid
- (obsolete) Authorized; real, genuine
and the adjective “illegitimate” as:
- Illegal; against the law
I don’t think there is any surprise here since these words are in fairly common use, but let’s apply these adjectives to the pharmaceutical supply chain. We could deduce:
The Legitimate Pharmaceutical Supply Chain: The chain of pharmaceutical supply that conforms to known and established legal forms, principles and requirements; the lawful supply chain; the valid supply chain; the real, the authorized, the genuine supply chain.
The Illegitimate Pharmaceutical Supply Chain: The illegal supply chain
Again, no surprises here.
We need one more definition: supply chain.
“A supply chain is the system of organizations, people, technology, activities, information and resources involved in moving a product or service from supplier to customer. …”
For pharmaceuticals, the supply chain begins with the manufacturer and ends with the consumer, or patient. (For logistical purposes we often talk of our supply chain beginning with the drug manufacturer and ending with the pharmacy, but in actual fact, it ends when the product is irreversibly consumed by the patient.)
We have a single legitimate pharmaceutical supply chain in the United States–filled with complexity, but singular nonetheless. I’ve heard people make the claim that “their [pharma] supply chain is secure”, as if there were many pharma supply chains and it is no concern of theirs if anyone else’s supply chain might not be secure. For security purposes we should treat the U.S. supply chain as a single entity. Martin Luther King famously once wrote, “Injustice anywhere is a threat to justice everywhere”. Similarly, in the pharma supply chain, it could be said that insecurity anywhere is a threat to security everywhere.
Likewise, I believe we have only one significant illegitimate supply chain: the internet. That’s a topic all on its own.
Both the legitimate and the illegitimate supply chains end with the consumer/patient. Interestingly, illegitimate drugs (counterfeit, stolen, diverted, up-labeled, adulterated) can reach the consumer/patient from both the legitimate and the illegitimate supply chains.
Here is perhaps the first surprise in this essay. If we have already separated the legitimate and the illegitimate pharma supply chains, how is it possible for illegitimate drugs to make it into the legitimate supply chain? Wouldn’t they only exist in the illegitimate supply chain?
The answer to the second question is “No”. I selected the adjectives “legitimate” and “illegitimate” for supply chains and for the drugs that pass in them. Just because the adjective is the same doesn’t mean that the subjects are bound to each other.
The answer to the first question is less intuitive. How do illegitimate drugs make it to consumers/patients through the legitimate supply chain? The answer is well documented in Katherine Eban’s book, “Dangerous Doses” already discussed in an earlier post. Look at the case of Timothy Fagan. His parents did not order his Epogen from a website. They bought it (in New York in 2002, prior to the crackdown on criminals in Florida…don’t miss my comments on how much has changed since then) from their favorite national chain pharmacy, a very solid participant in the legitimate pharma supply chain. But the Epogen was “counterfeit” (actually up-labeled and spoiled due to storage at improper temperatures) and Timothy nearly lost his life as the result.
In her book, Eban follows the path of the Epogen from manufacturer to Fagan. It’s a very interesting case. A legitimate drug started out in the legitimate supply chain and it was transformed into an illegitimate drug on its way to the consumer/patient. Did it exit the legitimate supply chain, get transformed by criminals and then get reintroduced, or was the transformation executed by criminals who had infiltrated the legitimate supply chain? The answer depends on whether all of the owners were properly licensed to buy and sell that type of pharmaceutical. If they were, then the drug did not exit the legitimate supply chain. Yes, one or more of the supply chain participants were criminal enterprises, but because they were licensed, they were a legitimate part of the legitimate pharma supply chain at the time.
The point is, individual or groups of criminals can infiltrate the legitimate supply chain at any point (even in big-name companies…read the book!). Once they do, illegitimate drugs can be introduced into the supply chain…easily.