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 →

Combination Products

Correction: Your Drug or Biologic Combination Product Is Probably NOT Exempt From The DQSA

December 16, 2013 Dirk Rodgers 2 Comments

Last month I published an essay that analyzed the exemption language related to combination products contained in the old California pedigree law and in H.R. 3204, which was later signed into law as the Drug Quality and Security Act (DQSA) (see “Drug-Device Combo Products Under State And Federal Pedigree Laws”). In that essay I showed how these exemptions were very similar because both were based on the existing definition of a “combination product” from 21 CFR 3.2(e). My assessment of the effect of the wording in the old California pedigree law is still valid, in my opinion, but I now believe my analysis of the language in H.R. 3204 was incorrect. Here is why. Continue reading Correction: Your Drug or Biologic Combination Product Is Probably NOT Exempt From The DQSA →

Barcodes

Will The FDA Eliminate The Linear Barcode On Drugs?

December 9, 2013 Dirk Rodgers 3 Comments

During last week’s FDA DQSA supply chain stakeholder’s conference call I was heartened by Ilisa Bernstein’s comments about the linear barcode rule (she says the FDA just calls it “the barcode rule”). The question was asked by a caller whether or not the linear barcode requirement might be dropped in light of the 2D barcode requirement contained in the Drug Quality and Security Act (DQSA) since some drug packages are too small to accommodate both barcodes. This is an excellent question and I was happy the caller asked it so directly.

In her response, Dr. Bernstein pointed out that Continue reading Will The FDA Eliminate The Linear Barcode On Drugs? →

DQSA of 2013

FDA: Ready, Set, Hike!

December 5, 2013 Dirk Rodgers 1 Comment

Tuesday’s FDA stakeholder call with Dr. Ilisa Bernstein, deputy director in the FDA’s Center for Drug Evaluation and Research (CDER) Office of Compliance, was helpful if only to let us know that the FDA has begun to mobilize immediately after the Drug Quality and Security Act (DQSA) was signed into law by President Obama last week (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law” and “InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13”). The call was very thin on what their plan is, but that was the point. Dr. Bernstein wanted everyone to know Continue reading FDA: Ready, Set, Hike! →