Supply Chain Integrity Reduces Threats of Counterfeit Drug Products
In a recent Flash Report, Rx-360.org offered a summary of the proposed USP Chapter 1083 – Good Distribution Practices – Supply Chain Integrity. In its report, Rx-360 noted that “globalization of all aspects of the pharmaceutical business has driven the need to address the threats of counterfeit or adulterated medication, devices and components, for which there have been several high-profile examples over the last few years.”
In February, counterfeit doses of Avastin, a cancer drug, were distributed in the United States.1 Medical practices were informed that the counterfeit versions had several obvious differences in the packaging and labeling, including missing information and altered lot numbers.
Counterfeit drug products represent a growing issue for the health care industry and pose an increasing threat to patient safety. Securing supply chain integrity can help to ensure that medicines can be traced back to their original manufacturer, are not adulterated or counterfeited and are transported to their intended destination with quality intact.
To avoid use of a counterfeit drug product, the World Health Organization recommends a visual inspection before a drug product is used.2 Signs of a counterfeit problem may include:
•False or incorrect labeling
•Evidence of tampering, including unseated stoppers or seals
West offers several solutions to aid in anti-counterfeiting. Our tamper-evident Flip-Off® seals and use of a specific color scheme for a container closure system may help caregivers and end users recognize a product at point of use.
West Spectraproprietary printing and embossing technologies give drug manufacturers multiple layers of anti-counterfeiting protection and can also provide point-of-use instructions such as cautionary statements at the item level. West also partners with customers to develop custom covert and sophisticated authentication solutions to support anti-counterfeiting programs.
1 “Counterfeit Doses of Avastin Distributed in the U.S.,” New York Times, Feb. 14, 2012, accessed on March 6, 2012. http://www.nytimes.com/2012/02/15/business/counterfeit-doses-of-avastin-distributed-in-the-us.html
2 World Health Organization’s International Medical Products Anti-Counterfeiting Taskforce (IMPACT), “Be Aware Toolkit for healthcare professionals,” http://www.who.int/impact/news/beaware/en/index.html, accessed on March 6, 2012.