Microscopy/Energy Dispersive Spectrometry (SEM/EDS) are often paired together in chemical testing. FTIR analysis is best used in testing organic materials and SEM/EDS primarily examines inorganic materials. Now, scientists are exploring their combined use in the world of counterfeit medicine.
Counterfeit drug manufacturers design the drugs to look identical to the real thing. These drugs are often produced in substandard conditions; they frequently can be incorrectly formulated and they may have the wrong amounts of active ingredients as well as harmful impurities.
There exists a considerable health risk for counterfeit drug use; patients’ illnesses could go untreated, they may face increased resistance to treatment and, even death, according to the World Health Organization (WHO).
A Growing Global Crisis
The WHO estimates that counterfeit drugs make up nearly 10 percent of the world’s pharmaceutical market. In developing countries, this climbs to 25 percent on average, with some countries as high as 70 percent. The counterfeit drug business doubled between 2005 and 2010 and reached $75 billion in annual sales, according to a new study published in February 2012.
Roger Bate, American Enterprise Institute resident scholar and author of Phake: The Deadly World of Falsified and Substandard Medicines, first came across dangerous drugs while evaluating HIV and malaria projects in South Africa nine years ago.
Patients died because counterfeit pills they were taking contained chalk, talcum powder, road paint and, at times, dangerous heavy metals. Bate estimates that the global trade in counterfeit drugs kills possibly 100,000 people each year.
Tracking Down the Source
The FDA’s Forensic Chemistry Center (FCC) examines evidence obtained in counterfeit drug investigations. While they perform a thorough chemical examination of the drugs, they complete only a visual examination of the drug’s packaging by checking for type of printing, various colors, etc.
In an effort to expand the government’s approach, four interdisciplinary scientists with the U.S. Food and Drug Administration (FDA) developed a method for the chemical analysis of the packaging. Using FTIR analysis and SEM/EDS, the scientists examined both counterfeit and authentic packaging. They’re using this initial procedure as a basis for creating a method which could be used on future sample submissions to the laboratory.
They concluded that the chemical profile provided by FTIR analysis and the elemental profile and site identification provided by SEM/EDS micro-analysis added points of comparison when determining product authenticity.
When combining this information with physical analysis of the packaging and chemical analysis of the product, a stronger conclusion can be made when declaring a suspect product “authentic” or “counterfeit.”
In addition, they found that chemical trends they observed in the packaging components may be able to help identify the source of the counterfeit products.
FTIR analysis and SEM/EDS are two techniques Innovatech Labs uses to identify components of unique samples. To learn more, subscribe to the Innovatech Labs Resource Center.