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 … Continue reading We Should Be Ashamed Of The U.S. Approach To Pharma Recalls
I did not participate in the development of the Pharmaceutical Traceability Enhancement Code (RxTEC), a proposed Congressional bill that was created by the industry lobbying group known as the Pharmaceutical Distribution Security Alliance (PDSA). In fact, while I was aware that a group had been formed last year I wasn’t aware that they were working … Continue reading What If RxTEC Isn’t Adopted?
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 … Continue reading Pew Prescription Project: After Heparin
Conversations about the merits of various pedigree and authentication models usually start from dissatisfaction with some characteristic of the current GS1 DPMS pedigree model. I maintain that the design of DPMS—including its perceived flaws—is merely a reflection of the current state and federal pedigree laws and regulations. Characteristics that people don’t like—like digital signatures, a … Continue reading What are Pedigree Laws Trying to Accomplish Anyway?