While R. Stahl, Waldenburg, Germany, is warning that dangerous knock-off products are circulating in the explosion-protection and prevention market, counterfeit pharmaceuticals pose another, far-more-extensive worldwide challenge..
The World Health Organization (WHO), Geneva, Switzerland, estimates that globally 10% of medication is counterfeit. Criminal trade in counterfeit medication is more prevalent in developing countries with weak drug regulation, control and enforcement, and where basic medicines are scarce or irregularly supplied and unaffordable. It’s endemic in southeast Asia and Africa, where the amount of counterfeit pharmaceuticals in circulation is more than 50% in some countries.
The most counterfeited drugs in developing countries are designed to fight malaria, tuberculosis and HIV/AIDS. In developed countries, hormones, corticosteroids, cancer drugs and retrovirals are common targets — along with lifestyle drugs which treat conditions such as sexual impotence, baldness and obesity, according to WHO. Now, the U. S. Food and Drug Administration (FDA) has taken a big step forward in its battle against counterfeit drugs.
[pullquote] It has issued draft guidance on use of inks, pigments, flavors and other physical-chemical identifiers (PCID) by manufacturers to make drug products more difficult for counterfeiters to duplicate, and to make it easier to identify genuine versions of drugs. It’s an important step in working with manufacturers.
“Drug counterfeiting is a serious public health concern,” says Margaret Hamburg, FDA commissioner of food and drugs. “We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective or harmful ingredients.”
The document aims to provide guidance to industry about use of PCIDs in solid oral dosage forms, which include pills and capsules, for anti-counterfeiting.
A PCID is a substance or combination of substances possessing a unique physical or chemical property used to identify and authenticate a drug product or dosage. In addition to inks, pigments and flavors, specific chemicals may be used as molecular tags in a PCID.
There are various available means for PCID presentation and detection, such as photolithography, holography, laser scanning devices and excitation/fluorescence detection. Many identifying characteristics, such as pigments or flavors, could be easily observed by patients, healthcare practitioners and pharmacies, says the FDA. Some might require instrumental detection, for example a scanner or photometric detector.
The FDA anticipates many potential PCID ingredients are already used as food additives, colorants or other types of inactive ingredients with established safety profiles. However, recent advances in X-ray diffraction (XRD) mean that it’s now possible to use the technique as a basis for phase identification and quantification of counterfeit pharmaceuticals.
One company leading the way is inXitu, Mountain View, Calif. Its portable field XRD analyzer TERRA, which took the Editors’ Choice Gold Prize at Pittcon in March, has been tailored for completely contained operation in remote environments and at all points in the global pharmaceutical supply chain. It can achieve qualitative and quantitative validations within two minutes.
The company’s Web site (www.inxitu.com/index.html) shows an example of such an analysis where a suspect batch of Viagra was found to consist of three mineral fillers: gypsum, bassinite and dolomite.
Meanwhile, Sun Chemical, Parsippany, N.J., one of the world’s largest producers of printing inks and pigments, has teamed up with track-and-trace services provider Pharmorx Security, Southborough, Mass., and label-and-carton manufacturer MSO Group, Belfast, Northern Ireland, to provide multi-layered brand protection solutions.
These solutions, which combine MSO’s advanced packaging products with Sun Chemical’s proprietary taggants and Pharmorx’s technologies and services, diminish counterfeiting, diversion and return-management issues by offering manufacturers the ability to track their products from distributor to wholesaler, to retailer, and in some cases to the consumer.
Pharmorx Security is introducing an iPhone authentication and track-and-trace application. It enables the iPhone to scan a 2D barcode that contains a unique serial number, lot code and expiration date of the product.
Because these codes have been generated by the Pharmorx AuthentiTrack system, data from the scan will be used to connect to the Authentitrack database. This allows consumers to authenticate products and access a wide range of data including product history, and promotional information such as discount coupons. Human readable codes also can be input into the iPhone.
“I think that our combined ability to offer unit dose serialization far exceeds what’s currently available in the brand protection market, states Steve Wood, Pharmorx president and CEO. This feature is exceedingly important, especially in the pharmaceutical industry where there are increasing safety requirements and growing initiatives for serialization such as what’s taking place in the European market.”
Seán Ottewell is Chemical Processing's Editor at Large. You can e-mail him at [email protected].
