The root cause of the US opioid epidemic was made visible on television two Sundays ago. Did you see it? I’m referring to the 60 Minutes/Washington Post expose called “The Whistleblower” that aired on Sunday, October 15. But if you watched that episode with the volume up, odds are you missed the root cause. Let me explain. Continue reading Opioid Epidemic: Root Cause Exposed
A “product grouping” is any collection of saleable units of products that are bound together in some way. They can be “bundles”, homogeneous or non-homogeneous cases, totes, pallets or something like these. The pharma serialization regulations in some markets call out some of these groupings for special treatment, and some do not. I’ll try to catalog what we know about product groupings in each of the current, known regulations. Continue reading Serializing Product Groupings Under Global Regulations
Last week I discussed controversy over the use of GS1’s Serial Shipping Container Code (SSCC) in the Brazil pharma supply chain to meet regulatory requirements imposed by ANVISA. But there are different controversies, or at least potential confusion, in the U.S. pharma supply chain surrounding case labels, and some of those are relate to the SSCC and its use.
A case product identification label is the label a manufacturer usually places on each homogeneous case at case-packing time to identify what is inside the corrugated box. A “homogenous case” is a case that Continue reading Identification Of Pharma Cases In The U.S.
Last Thursday a bipartisan group of U.S. Senators and Representatives jointly introduced a bicameral bill that would significantly increase the criminal penalties for drug counterfeiting to as much as 20 years in prison, as reported by Phil Taylor in SecuringPharma (see the article for the details). The house bill is called H. R. 3468, The Counterfeit Drug Penalty Enhancement Act. The group of legislators include U.S. Senators Patrick Leahy (D-VT), Chuck Grassley (R-IA), Michael Bennet (D-CO), and Richard Blumenthal (D-CT) and U.S. Representatives Patrick Meehan (R-PA) and Linda Sánchez (D-CA). Not surprisingly the responses from the Pharmaceutical Research and Manufacturers of America (PhRMA) and Pfizer were swift and supportive.
Raising the penalties for counterfeiting drugs to the point where they adequately reflect the widespread harm they can cause the public is a very good thing. It should have the effect of making people think twice about selling counterfeit drugs to Americans through the internet or attempting to introduce them into the legitimate supply chain (brick-and-mortar and legitimate internet pharmacies). It may even cause more people in the legitimate supply chain to Continue reading STEP #1: Raise Penalties For Drug Crimes To Reflect The Widespread Harm They Can Inflict
Several people I know from the traceability solution provider community like to tout the similarities between the food supply chain and the pharmaceutical supply chain. They see similar track and trace regulation in the futures of both chains. After all, both supply chains are regulated by the same agency (FDA, although food is also regulated by the USDA) and they see them as having similar problems. But I don’t buy all that. My friends see the use of common tools (their products, of course) and I might give them that, but these two problems only seem similar on the surface and so, if track and trace regulation is needed for both, the two regulations ought to have only high-level similarities.
THE FOOD SUPPLY CHAIN
The increasing frequency of the scariest problems in the food supply chain are related to accidents—like unintended contact with surfaces or organic matter that contaminate the food with nasty things like E. coli or salmonella—or food that has spoiled as the result of improper storage somewhere in the supply chain—like refrigerators or freezers that aren’t doing their job. Consumers would benefit from the use of food track and trace in situations like these only when the contamination or spoilage isn’t detected until after the product is split up and distributed down multiple paths. The track and trace system would improve the speed of the recall and the confidence in its completeness.
Generally, food is distributed to retail outlets inside containers that are packed by the manufacturer or processor. I’m not an expert here so those of you who are, please correct me, but I don’t think food distributors normally break down cases and ship individual saleable units to retailers. I think they normally ship full cases, bins and pallets. For this reason, item-level serialization is not critical to end-to-end track and trace. However, container-level serialization-based track and trace would be a major benefit to this supply chain.
There is one more thing about the food supply chain that I think is significant for this discussion. Many of the trading partners at the start of the supply chain are small, independent and technically unsophisticated. Most of the trading partners at the end of the supply chain are just the opposite: large corporations with big IT budgets.
THE PHARMACEUTICAL SUPPLY CHAIN
On the other hand, the scariest problems in the pharmaceutical supply chain Continue reading The Deputized Supply Chain