Fake Avastin reveals weaknesses in pharma supply chain

OVUM VIEW

Summary

The counterfeit vials of Roche’s monoclonal antibody cancer therapy drug, Avastin, entered the US healthcare system through a foreign supplier after passing undetected through several distributors in at least three western European countries. Although the investigation is still ongoing, the initial indications suggest that the counterfeits originated in Turkey and passed through Egypt before entering Western Europe. This latest episode of counterfeit medication entering the legitimate distribution network highlights the complexity and geographically diverse nature of the pharmaceutical supply chain. It also underscores the ease with which counterfeit medicines can pass undetected through established distributors and wholesalers in western industrialized nations and into the point of care.

High-quality fake packaging and low prosecution risk are increasing the proliferation of counterfeits

Counterfeit branded medications represent a low-risk, high-return activity for criminals. Combating counterfeiting crime is difficult for a variety of reasons, but the overriding issue is the difficulty in identifying and quantifying the damages. Without this information, pharma and law-enforcement agencies have an uphill battle to be able to pass more punitive laws, obtain the cooperation of foreign authorities, and receive additional funding and support. While the risks for criminals are low the damage to brand images, business reputations throughout the supply chain, and consumer faith are significant – not to mention the potential risk to patients. Counterfeiters’ methods have become increasingly sophisticated, rendering the fake packaging nearly indiscernible from the legitimate packaging. Thus, patients and healthcare practitioners cannot rely upon visual inspection to spot fake packaging or to recognize invalid lot numbers to validate the authenticity of our medications. Track-and-trace technology exists to alleviate this burden and governments around the world are implementing related regulation to mandate enforcement.

Local and national governments are enacting track-and-trace regulations

California is requiring pharmaceutical manufacturers to implement the necessary technology to create an item-level “pedigree” for 50% of their drug shipments in 2015 and the remaining 50% in 2016. Track-and-trace solutions use unique barcodes and RFID tags to uniquely identify authentic drug packages and pallets. These identifiers are scanned at each step along the way to the dispensing point, to create an electronic record of the drug’s movements, known as an electronic pedigree or e-pedigree. Application of such technology will not only greatly enhance the security of the supply chain and ease validation of medications but also enable rapid recalls and combat the resale of stolen or diverted supplies. While California is the first state to implement such regulation, the FDA is moving towards a federal solution and published standards for item-level serial numbers in 2010. A timeline for a nationwide mandate by the FDA remains unclear as bills introduced in Congress to grant the FDA with the necessary authority have not progressed and the FDA has not disclosed if it will act without congressional authorization. Meanwhile, many other national governments are requiring certain levels of serialization within the 2015–2016 timeframe.

Although track-and-trace solutions are a necessary and important step towards combating counterfeit drugs, they require a highly sophisticated infrastructure at the international level in order to function properly, which will require significant coordination and investment from many stakeholders within the ecosystem. As a result, other technologies such as mobile product authentication (MPA) are also being developed to catch fake medications. With the increasing proliferation of mobile devices such as smartphones, pharmaceutical manufacturers have started using scannable QR codes or scratchable code fields to enable consumers to determine the authenticity of drug packaging at the point of purchase. While not foolproof, this technology does provide assurance to the consumer about the authenticity of the medication, especially in emerging markets where there is a high incidence of counterfeit drugs and a lack of infrastructure to support more sophisticated authentication systems.

Enterprises should monitor developments and evaluate implementation plans

Due to the complex and global nature of the pharmaceutical supply chain, enterprises should monitor developments in the countries in which they operate and plan accordingly. A pilot involving 2D barcodes to satisfy recent amendments to the EU Pharma Directive will commence in 2013. Pharmaceutical manufacturers should either participate in or monitor such pilots and adjust their mid-range planning and budgetary allocations accordingly. As regulatory deadlines approach the demand for qualified resources to implement necessary track-and-trace solutions could outstrip supplies. Therefore, pharmaceutical manufacturers are encouraged to develop the necessary capability to ensure future regulatory compliance as soon as possible.

APPENDIX

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