PHARMACEUTICAL SUPPLY CHAINS IN THE NEWS, FOR THE WRONG REASONS

Extreme caution required

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 unexp…