Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation

August 6, 2018 Dirk Rodgers 11 Comments

View of a layer of drug cartons inside a case. Photo courtesy of Omega Design. Click image to enlarge.

Neither the Drug Supply Chain Security Act (DSCSA) in the United States, nor the Falsified Medicines Directive (FMD) in the European Union explicitly mandates the capture or use of aggregation data (see “Aggregation –> Chargeback Accuracy –> ROI” and “EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary“). In this instance, “aggregation data” is data that documents the serialized packaging containment hierarchy of drug products—also known as “parent-child relationships”. It is well established that companies are not required by law to capture it, but for the smooth operation of pharma supply chains under a serialization, tracing and/or verification regulation, high quality aggregation data will be necessary. But there are warning signs that a significant percentage of drug manufacturers are not going to meet that bar by the deadlines. Continue reading Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation →

Personalized Medicines, serialization

Personalized Medicines In A Serialized World

July 30, 2018 Dirk Rodgers

3d render of T cells attacking cancer cells

The era of personalized medicines has begun. These are medicines that are tailored specifically for a single patient, using that patient’s specific DNA or other blood characteristic as a guide or actual source component. The new chimeric antigen receptor T-cells (CAR-T) is an exciting example. It results in the conversion of a patient’s own T-cells into cells that are able to recognize the specific type of cancer cells that the patient has, and thus able to attack them in the same way that normal T-cells attack normal infectious cells. In short, it’s a way of manipulating a person’s own immune system to attack cancer cells that it would normally be blind to. When it works, the results can be breathtaking. The question is, how are these drugs treated under today’s serialization and tracing regulations? Let’s take a look. Continue reading Personalized Medicines In A Serialized World →

Russia

New Direction For Pharma Serialization In The Russian Federation

July 23, 2018 Dirk Rodgers 1 Comment

Click image to enlarge. Image from www.GreenwichMeanTime.com

Over the last 18 months or so, the Ministry of Health in the Russian Federation has been conducting a pilot to learn what works and what doesn’t work for pharma serialization and tracing (see “Russia Begins Its Pharma Supply Chain Pilot” and “The Russia Serialization Pilot Guideline”). They were due to publish a report on their findings in February of this year, but we are still watching for that. As we’ve learned over the years, it’s not uncommon for governments to miss their deadlines, at the same time, making tough statements about the industry needing to meet theirs, followed by caving on those deadlines too (See US, China, Brazil, US, India, Pakistan…). That pattern is repeating in Russia. Continue reading New Direction For Pharma Serialization In The Russian Federation →

DSCSA

HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance

July 16, 2018 Dirk Rodgers

Unlike the implication of this drawing, FDA does hear and care about submitted comments.

The Healthcare Distribution Alliance (HDA) recently posted their response to the latest draft Drug Supply Chain Security Act (DSCSA) guidance published by the FDA. That draft guidance explains how, when and why companies in the US pharma supply chain can apply for waivers, exemptions and exceptions to provisions in the DSCSA (see “FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption”). As usual, the HDA took close to the full sixty day comment period to respond. The comment period closed last Monday. Continue reading HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance →

DSCSA

Newly Published Material From HDA and C4SCS

July 10, 2018 Dirk Rodgers

I was on vacation last week and only arrived home Sunday evening so I didn’t have time to write an essay for Monday, but this is Tuesday! Near the end of last month there was a spike in the number of things that need to be covered in RxTrace. Two of them are important things from HDA and the Center For Supply Chain Studies. I’ve been waiting for both for months, and here they are. Continue reading Newly Published Material From HDA and C4SCS →

RxTrace

RxTrace: Year Nine

July 2, 2018 Dirk Rodgers 1 Comment

Led Zeppelin: In Through The Out Door — In Through The Out Door

The ninth year of RxTrace ends on the Fourth of July, 2018. This year has been marked by a resurgence of activity by the FDA aimed at their obligations under the Drug Supply Chain Security Act (DSCSA). In the last 12 months we have seen the FDA Continue reading RxTrace: Year Nine →

DSCSA

DSCSA Makes M&A More Complex/Risky/Costly

June 25, 2018 Dirk Rodgers

When companies are thinking about merging or acquiring (M&A) other companies, or product lines from other companies, they typically engage in a process known as “due diligence” to discover any hidden risks that might come along with the action. In the pharma industry the risks are huge, so this activity is intense and costly. Discovery of larger risks than expected can result in the abandonment of the M&A plan, or can result in the adjustment of the price—usually downward. Now that pharma supply chain companies in the US are required to retain detailed transaction information about every purchase and sale of prescription drugs for six years, and must respond to verification requests over the life of the product, due diligence is now more complex and risky, and so it is more important than ever. Continue reading DSCSA Makes M&A More Complex/Risky/Costly →

DSCSA

DSCSA: Why FDA Will Not Mandate Blockchain, EPCIS Or Any Other Specific Technology

June 18, 2018 Dirk Rodgers

There are a lot of discussions going on in the industry right now, over which approach and which technologies the US pharma supply chain should select to meet the 2023 requirements of the Drug Supply Chain Security Act (DSCSA). People are understandably confused over these discussions. Why should we guess what the FDA will accept in 2023? Blockchain? EPCIS? Aren’t these debates and discussions just a waste of our time? Why doesn’t the FDA just tell us which technology they will accept for the DSCSA in 2023? In fact, these questions have become so common lately that I think it is time to examine what is going on. There are definitive answers to these questions, and they are contained within the DSCSA itself. Continue reading DSCSA: Why FDA Will Not Mandate Blockchain, EPCIS Or Any Other Specific Technology →

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance