DQSA: Did The Authors Get The Timeline Right?

February 3, 2014 Dirk Rodgers 2 Comments

In the last update by the California Legislature, the timeline for the rollout of the California pedigree law was spread out so that it was to take 2 ½ years from the first manufacturer deadline for serialization of 50% of their product until everything was serialized, pedigreed and wholesalers and pharmacies were making use of the serial numbers and pedigrees. Of course, everyone should be aware by now that the U.S. Drug Quality and Security Act (DQSA) preempted that law and all State and Federal pharma serialization and pedigree laws, and replaced them with new Federal requirements that have a different rollout timeline.

The track and trace provisions of the DQSA are defined within Title II of that act, known as the Drug Supply Chain Security Act (DSCSA). Some of its provisions begin next January. Some start in November of 2017 and some start in 2023. Continue reading DQSA: Did The Authors Get The Timeline Right? →

DQSA of 2013

How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2

January 27, 2014 Dirk Rodgers 5 Comments

Last week I published an overly long essay about how the supply chain provisions of the new U.S. Federal DQSA will and won’t protect the pharma supply chain. Believe it or not, I had more to say on the subject, but because that essay was already too long, I withheld my additional thoughts until now. Part 1 took another look at a number of supply chain crimes that have occurred over the last 5 to 6 years and attempted to determine how the new Drug Supply Chain Security Act (DSCSA) that is contained within the DQSA will add new protections that will or won’t help prevent crimes like them in the future.

In this Part 2 essay I want to look at the issue in a different way. I’d like to compare the approach that Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2 →

DQSA of 2013

How the DQSA Will–And Won’t–Protect The Supply Chain, Part 1

January 22, 2014 Dirk Rodgers

The supply chain provisions contained within the Drug Quality and Security Act (DQSA)—themselves known as the Drug Supply Chain Security Act (DSCSA)—mark a significant achievement by Congress and the industry to protect the U.S. pharmaceutical supply chain from criminals. It is the first completed attempt since 1987 when the Prescription Drug Marketing Act (PDMA) was enacted by Congress and signed by President Ronald Reagan. In comparison, the provisions of the DSCSA are much more detailed and extensive than the PDMA and they read as if they were heavily influenced by people who solidly understand the scale and complexity of the legitimate supply chain. Which, they were, based on the contribution of the Pharmaceutical Distribution Security Alliance (PDSA)—made up of key stakeholders in the supply chain—in their development. That should ensure that the industry will be able to adopt the technology and process modifications necessary to meet the new law on time.

But will all this also lead to true protection of the supply chain from criminal activities? Will the DSCSA portion of the DQSA end up presenting new and insurmountable barriers against criminals who game the supply chain to their advantage and thereby putting patients at risk? These are the true measures of the success of this type of legislation. How can we know if the DSCSA will have these positive affects? Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 1 →

Global Alignment

Don’t Skip The DQSA Definition of Terms Section

January 13, 2014 Dirk Rodgers 1 Comment

Lots of people across the U.S. pharma supply chain are spending their spare time these days trying to read and understand the U.S. Federal Drug Quality and Security Act (DQSA) that was enacted in November and begins to take effect in a significant way next January (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”). I am one of those people.

I have carried a printout of Title II (the Drug Supply Chain Security Act, or DSCSA) of the DQSA around with me ever since it was passed and it is now so dog-eared and marked up that I am about ready to print out another copy. Only trouble is, I would need most of those markings in the new copy too, so I just keep using the same printout.

My understanding of the law and its implications rises every time I study it. Sometimes Continue reading Don’t Skip The DQSA Definition of Terms Section →

Data analytics, Drug diversion

Detecting Drug Diversion With Data Analytics–An RxTrace Interview With Analytics Expert Kosta Tzavaras

January 6, 2014 Dirk Rodgers 5 Comments

This week I have a special treat to share with RxTrace readers. It is an interview I recently conducted with Kosta Tzavaras, author, publisher, leading data management expert in the pharmaceutical industry and Solutions Manager with Phi Systems in Thousand Oaks, California. Kosta is a consultant to pharma and biotech manufacturers specializing in data analytics using supply chain and reimbursement data to help detect various kinds of drug diversion.

The original interview was conducted last summer and we updated it last week to reflect the recent passage of the Federal Drug Quality and Security Act.

Dirk: Welcome Kosta. Please describe your business…what it is that you do at a high level?

Kosta: Phi Systems is focusing in a niche area within the brand protection business in pharmaceuticals dealing with provider type of diversion, that is where healthcare providers are involved. The two particular areas I’m focusing on are physician office diversion—diversion that is enabled by the actions of certain physicians and their practices—and the second has to do with 340B diversion or PHS (Public Health Services) account diversion. That is diversion enabled, again, by Continue reading Detecting Drug Diversion With Data Analytics–An RxTrace Interview With Analytics Expert Kosta Tzavaras →

Writing

This Is Not Journalism

December 30, 2013 Dirk Rodgers 9 Comments

One of my four brothers has a journalism degree with a photojournalism emphasis from Northern Illinois University. Randy started his career at the Kewanee Star Courier (Illinois) as a photographer back in the 1980’s, before the internet became a place where many people looked for their daily news. His next career move was to become the editor of our home-town weekly newspaper, the Galva News (Illinois)—still before the internet news boom. I lived in Wisconsin at the time but I subscribed to the Galva News so I could read his essays. He produced a regular weekly column where he often wrote comical essays about what it was like to grow up in our family with five little boys, one big boy (our dad) and one regular adult (our mom). Lots of really great writing.

But, working for small-town newspapers, Randy did not just take photographs for publication, he also wrote news articles for both newspapers. That is, he was not just a photojournalist, he was a full journalist.

I, on the other hand, was trained as an engineer. I have never really thought the term “web log” described the contents of RxTrace very well but Continue reading This Is Not Journalism →

RxTrace

Rest Up, 2014 Will Be Very Busy

December 23, 2013 Dirk Rodgers 2 Comments

I really enjoy this time of year because business demands usually slow down enough to allow for me to catch up on some things I have neglected, review the year and do some planning for the coming year. I always take time to backup my computers and clean out my email. I do a lot of introspective thinking during the last two weeks of the year, and I normally like to do some writing that is way outside my normal fare. This year I may not have time for some of that because we plan to spend a lot of time with our family. I hope you are able to do that too.

Next year looks like it is going to be very busy for those who follow RxTrace because Continue reading Rest Up, 2014 Will Be Very Busy →