Thursday, September 24, 2009

New England Journal Medicine: Multinational Medicines — Ensuring Drug Quality In an Era of Global Manufacturing

In the August 20, 2009 issue of the New England Journal of Medicine, Susan Okie, MD writes about the emerging health care issue regarding the quality of branded and generic drugs in the new era of a globalized pharmaceutical supply chain.

In this new global economic age, Dr. Okie describes the problem and proliferation of a major global health care epidemic due to quality control and fraudulent prescription medications that are manufactured overseas in countries with a poor record of quality processes. In the article Dr. Okie also writes about the challenge of regulation and oversight as many pharmaceutical manufacturers and providers move their supply chain overseas to make and procure medications.

One of the more disturbing examples of the potential danger of lack of quality oversight regards the super potency of Digitek in 2008:

"…FDA’s Adverse Event Reporting System (AERS) contains data on adverse reactions to medications in a self selected subgroup of an exposed population of unknown size. In April 2008, the FDA and Actavis Totowa, the manufacturer of Digitek, a widely prescribed generic digoxin, announced a nationwide recall of 800 million tablets, triggered by concern that double-thickness tablets containing twice the approved dose might have been released commercially. Between April and September 2008, AERS received reports of 2,912 serious injuries and 1,094 deaths associated with digoxin, about 80% of them linked to the recalled product. Thomas Moore and colleagues at the nonprofit Institute for Safe Medication Practices have called for systematic testing of the recalled tablets, commenting that “if many of these cases prove to be linked to manufacturing problems, then the nation has experienced a little noted drug disaster of major proportions.”

As have been reported in this blog for sometime the incidents of recalls related to lack of quality control and oversight connected to product production has spiked in the past several years and according to Dr. Okie may continue to increase due to the FDA’s lack of resources.

XStream Systems endorses the concept that both private industry and government regulatory agencies use technology such as XStream’s XT250 to screen, authenticate and verify the contents of products within the supply chain from point of production to the consumer. By using a material screening process, which verifies the material inside its unit-of-sale container, the entire supply chain mitigates its liability and ensures the consumer that the product is safe and efficacious. The current costs of the issue of poor quality medications within both the supply chain and the health care of the consumers, seems nearly impossible to effectively gauge or predict but it seems reasonable that whatever the price, the costs in both dollars and human suffering are far too high. Through proper verification within the supply chain, XStream feels that many of these incidents can be averted and the health care of the consumer protected.

To view Dr. Okie’s article in the August 20, 2009 issue of the New England Journal of Medicine, visit their website at:

To learn more about XStream Systems verification technology, visit:

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