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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
•Improper packaging
•Evidence of tampering, including unseated stoppers or seals
•Missing information
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.
Gene therapies are developed by modifying a person’s genes and are often targeted to treat complex and chronic diseases. Due to advancements in science and research, gene therapy is positioned to transform treatment options for patients who are living with these incurable diseases. There is a growing pipeline of gene therapies globally, with 352 global trials underway at the end of 2019, up 12% from 2017.<sup>1.</sup>
As a caring corporate citizen, West has established a long-standing tradition of supporting the communities in which we work and live. Our comprehensive philanthropic efforts include three programs: 1) corporate giving through West, 2) the Herman O. West Foundation, a separate 501(c)(3) entity, and 3) our employee-led fundraising program, West without Borders.
Good container closure integrity (CCI) is an essential feature in preserving the sterility of a drug package over its shelf life. How sterility has been demonstrated, however, has changed substantially over the past 30 years.
Container closure integrity (CCI) has been a fundamental core requirement of containment and delivery solutions in the West product portfolio. Container closure systems (CCSs) must maintain both the sterility and stability of pharmaceutical products; very importantly they must be free of microbial contamination. Microbial ingress into a CCS will jeopardize product sterility.
A European Customer Satisfaction Study conducted in 2012 offered West customers a chance to be heard, and provided a contribution to the José Carreras Leukämie-Stiftung (José Carreras Leukemia Foundation) based in Munich, Germany. The EU-wide study was conducted as an online survey and ran throughout the summer. To encourage customer participation, West made a charitable contribution for each completed survey. Thanks to a high level of customer participation (customers from 28 countries provided feedback), West was able to generate €2,260 (more than $3,000) for the charity.
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