All Eyes on Safety and Brand Protection
Counterfeit drug sales tarnish a pharmaceutical brand’s reputation and take a toll on sales, but more importantly, they carry major health risks for consumers. According to the National Crime Prevention Council, up to 10 percent of the global pharmaceutical supply chain may be counterfeit. The projections jump to 70 percent in developing countries.
Pharmaceutical counterfeiting poses a dangerous challenge to the industry as a whole. For years, the issue has prompted widespread regulations aimed at authenticating and tracking pharmaceutical products throughout the supply chain. With the new Drug Quality and Security Act passed in the United States in November 2013, pharmaceutical manufacturers are required to add serial numbers to all packages and labels within the next four years. These labels must be upgraded to electronic codes within 10 years.
By enforcing a nationwide standard for track-and-trace measures, this legislation will streamline compliance efforts with other state initiatives, such as California’s E-Pedigree Law. Fortunately for manufacturers looking to meet these new standards, there are many advanced technologies and processes designed to make compliance simple, effective and efficient.
Radiofrequency identification (RFID) tags, which are unique to each product and very difficult to alter or replicate, can enhance the traceability of a product. Scanning the RFID tab and examining the product’s ePedigree, an electronic document providing data on the batch history of a particular drug, allows pharmacists and wholesalers to determine the identity, composition and dosage of ingredients in the drug, as well as its path through the supply chain. If a counterfeit drug is identified, a product recall can be efficiently executed due to the RFID’s tracking system.
Vital Data Monitoring
Pharmaceutical manufacturers are responsible for safeguarding the drug data, which will become a part of a patient’s confidentiality record. Monitoring data from production to the patient can be achieved through embedded coding and tracking systems. New technologies can help accurately code this data by affixing lot codes, product serial numbers and manufacturing dates to the package. These solutions provide easy tracking and allow visual verification to ensure the code and package match up.
Seamless Integration & Accuracy
Industry engineers can utilize intelligent technologies that seamlessly integrate layer aggregation technologies, case loading tables and printers, touchscreen consoles, connectivity to data management systems and hand-held scanners. The resulting systems can handle labeling and serialization on loose or bundled bottles and cartons, and can also be configured for manual or semi-automatic operation, providing pharmaceutical manufacturers with accurate and flexible labeling capabilities.
To stay compliant with regulations, pharmaceutical manufacturers must meet their deadline for implementing new track-and-trace solutions. Pharma EXPO 2014 (Nov. 2–5; McCormick Place, Chicago) will provide the solutions and insight for the simple, effective transition they seek.
Co-located with PACK EXPO International 2014, the event is jointly produced by PMMI, The Association for Packaging and Processing Technologies, and the International Society for Pharmaceutical Engineering (ISPE). Pharma EXPO will present technologies for the entire pharmaceutical processing and packaging supply chain with ISPE’s world-class educational conference, making it the most effective industry resource available to secure the tools to combat counterfeiting. Attendees will also have access to the PACK EXPO International show floor. Together, the two shows will draw more than 50,000 attendees and over 2,000 exhibitors to 1.1 million net square feet of exhibit space.
To be notified when registration opens, visit pharmaexpo.com.
PMMI, The Association for Packaging and Processing Technologies, is a trade association representing over 600 packaging and processing supply chain companies that provide a full range of packaging and processing machinery, materials, components and containers. PMMI actively brings buyers and sellers together through programs and events such as The PACK EXPO family of trade shows, packexpo.com, PMT Magazine, PACK EXPO Show Daily, networking events and educational programs.
PMMI organizes the PACK EXPO trade shows: PACK EXPO International, Pharma EXPO, co-located with PACK EXPO International and presented jointly with the International Society for Pharmaceutical Engineering (ISPE); PACK EXPO Las Vegas, PACK EXPO East, EXPO PACK México and EXPO PACK Guadalajara, connecting participants in the packaging and processing supply chain with their customers around the world. Coming Up: EXPO PACK México 2014, June 17-20 (Mexico City, Mexico); PACK EXPO International 2014, Nov. 2-5 (McCormick Place, Chicago); Pharma EXPO, co-located with PACK EXPO International 2014; PACK EXPO East, debuting Feb. 2–4, 2015 (Pennsylvania Convention Center, Philadelphia); EXPO PACK Guadalajara 2015, March 18-20, 2015 (Guadalajara, Jalisco, Mexico).
Learn more about PMMI and the PACK EXPO trade shows at PMMI.org and Packexpo.com.
ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA and offices in Brussels, Belgium, Singapore and Shanghai, China and is publisher of Pharmaceutical Engineering Magazine. Visit www.ISPE.org for more information.