PHARMACEUTICAL SUPPLY CHAINS IN THE NEWS, FOR THE WRONG REASONS
Re-posted from Jan 2022:
THE HEPARIN TRAGEDY
In 2007/8, pharmaceutical supply chains became the subject of global debate among key stakeholders, but for the wrong reasons.
A tragic event occurred that shocked the world into realizing that pharmaceutical supply chains had the potential to kill and maim unsuspecting patients.
A blood thinning agent, heparin, had been adulterated [weakened or lessened in purity by the addition of a foreign or inferior substance or element] due to the product license holder (Baxter) procuring a toxic substance that had been illegally substituted for the genuine registered material.
The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs). The full account of this has been documented in the report: After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs, authored by PEW Health Group.
This is an extract from the PEW HEALTH GROUP summary:
“In late 2007, US health officials began receiving reports of unexpected allergic-type reactions in patients undergoing dialysis. The reactions were linked to a widely used blood thinner—heparin—and specifically to an adulterant that had been introduced during manufacture of the drug in China.”
It goes on to say:
“…drug manufacturing and distribution has become increasingly complex in recent years. Prescription and over-the-counter (OTC) medications originate in factories all over the world, moving into the American marketplace through supply chains that can involve numerous processing plants, manufacturers, suppliers, brokers, packagers, and distributors.”
“Increasingly, the United States relies on drug manufacturing in developing countries—mainly China and India. Globalization, increased outsourcing of manufacturing, the complexity of pharmaceutical distribution, and the existence of criminal actors willing to capitalize on supply chain weaknesses has created the potential for counterfeit or substandard medicines to enter the system and reach patients. As evidenced by the adulteration of heparin and other case studies outlined in this report, these rare but potentially serious events can have grave consequences.”
In June, 2010, I was asked to present on the topic of supply chain security and pedigree at the US FDA/Xavier Health co-sponsored Global Outsourcing Conference.