Authentication and track and trace methods, like pedigree, should be combined to provide layers of protection against counterfeit drugs according to XStream Systems’ CEO Brian Mayo.
XStream’s X250 energy dispersive x-ray diffraction (EDXD) technology, which is used to identify the molecular contents of sealed products, was recently employed by a major US drug distributor to authenticate 20,000 bottles at a single site.
Although unable to provide many more details for security reasons, Mayo did disclose that the products examined included treatments for HIV, cancer, psychosis, viral infection and heart medicines.
Mayo explained that for pharmaceutical distributors that are unable to open drug products, the problems of securing supply chains against fakes and adulterated products are compounded.
He cited a recent example at one of the firm’s clients where a weighing system was used to detect counterfeits on the basis that they would not match the authentic products.
“However, counterfeiters knowing this, simply mixed and matched various weight counterfeit pills to reproduce the same overall weight of the bottle. Our system was successful in detecting the molecular differences of the pills inside and identifying that they were counterfeit.”
Mayo added that while, at present, the US Food and Drug Administration (FDA) does not set rules for equipment use after a drug has been manufactured and packaged, XStream has started to collaborate on developing a set of standards.
He went on to say that: “While pedigree laws help with issues such as diversion, drugs may still be counterfeited, adulterated, dosage changed, or contaminated and still have a valid pedigree because when any drug changes hands there is a possibility for foul play.”
Mayo suggested that at present “everybody trusts that the supplier further up the chain is looking out for their best interest. In actuality, it should be up to each receiving area to verify the drugs before they are allowed into their central inventory.”
This idea is supported by last year’s problems with heparin, where over-sulfated chondroitin sulfate (OSCS) was substituted for the genuine active pharmaceutical ingredient (API) by a manufacturer in China before being fed into the complex global supply network.