In addition to globalisation, high financial rewards and low penalties for counterfeiters are contributing to the rise in fake medicines. Although some progress has been made in several countries to address drug counterfeiting, success is variable and, despite seeing a reduction in counterfeiting for (e.g., Pfizer’s success in reducing Viagra counterfeits), the problem has not been eradicated.
Tighter regulations have helped improve the detection of counterfeit products at various stages of the supply chain and prosecutions appear to be increasing. Pharmaceutical manufacturers, while working to comply with the numerous and varied regulations to prevent counterfeiting, have also undertaken their own initiatives to protect their brands. For example, companies are applying radio-frequency identification (RFID) tags to individual packages and using covert (e.g., tagents, holograms, colour shifting inks) and overt (e.g., tamper-evident seals, barcodes) methods.
However, one method alone is usually not sufficient to prevent counterfeiting, says Janice Kite, traceability director of GS1 Healthcare.PharmTech spoke to Kite about global collaboration to address these challenges. GS1 is an international not-for-profit association with member organisations in more than 100 countries. The association is dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors. Part of the association involves GS1 Healthcare, which is a voluntary global healthcare user group that brings together stakeholders from pharmaceutical and medical-device companies; wholesalers, purchasers, and distributors; hospitals and pharmacies; logistics providers; and governmental and regulatory bodies. The mission of GS1 Healthcare is to lead the healthcare sector to the successful development and implementation of global standards that enhance patient safety and supply-chain efficiencies.
GS1 has developed a system of standards (available at http://www.gs1.org/docs/GS1_System_of_Standards.pdf) that is meant to be used by stakeholders as a best practice for increasing supply-chain security and improving patient safety. According to Kite, regulators in Turkey, Argentina, and Australia are currently following the GS1 system of standards, and many pharmaceutical companies are already using the GS1 standards for the identification of their products.