“Geopolitical environmental scanning” seems to be the new catch phrase in supply chain security. The term came up multiple times during the ISPE conference and during the launch meeting of the Rx-360 consortium, both of which took place in Washington, DC, the first week of June.
IPEC–Americas Chair Janeen Skutnik mentioned geopolitical environmental scanning as a way to detect, in advance, potential weaknesses in or disruptions to the supply chain that could lead to contamination, adulteration, or counterfeiting. For example, we all know that heparin is made from pig intestines and that most pigs in the world are raised in China. Well, before the heparin contamination incident, the price of pigs in China kept going up. This increase in price could have led to the replacement of quality heparin ingredients with a cheaper ingredient that didn’t come from pigs. The fact that the price of a key “ingredient,” if you will, for a major drug was going up, should have raised a red flag to industry that the supply chain for this drug product may be affected negatively.
This lesson has led many pharma companies to change the way they monitor their supply chains by examining—or rather, hiring a third party to examine—all sorts of geopolitical and environmental events (e.g., product shortages, labor unrest, even bad weather) that could affect their product lines.
One particular company, Beroe, was represented at the Rx-360 launch meeting. Beroe is a supply-chain monitoring company that, for a fee, monitors risks and disruptions around the world and then overlays them with a company’s supply chain to provide alerts regarding potential problem areas.
If you wait for a shortage to occur, such as the recent acetonitrile shortage, it may be too late, said Beroe’s CEO Vel Dhinagaravel, at the Rx-360 meeting. At that point, you end up paying more money for something you need or you are forced to use a less expensive (perhaps, less quality) supplier. It’s important to know what’s happening in the areas where your Tier 2 and Tier 3 suppliers are based—you can’t just follow your primary suppliers. “Our research has shown that only about 7% of supply disruptions are caused by financial problems at 1st tier suppliers,” according to Beroe’s website.
This new trend seems wise—albeit time-consuming and costly—to help predict and perhaps prevent adulterated, contaminated, or counterfeit drug products.