Global Regulations Help Protect the Healthcare Supply Chain

Nearly all branded healthcare products have been counterfeited. However, regulators, manufacturers, and other concerned parties agree that track and trace using serialization and other markers on product packaging can help secure the supply chain. This is leading to increased regulation in the United States and elsewhere.

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Counterfeit pharmaceuticals, recalls and quality challenges are an ongoing problem worldwide, and particularly in emerging geographies. Most recently counterfeiters infiltrated the biotech supply chain forcing the manufacturer to recall the fake version of the anti-caner drug. The drug’s maker, Roche Holding AG, said it had warned doctors, hospitals and patient groups that a counterfeit version of the medicine has been found in the United States. It isn’t clear how much of the counterfeit product was distributed in the United States or whether it has caused any harm. The company told the news that it doesn’t know whether any patients were given the fake drug. This report and many others are sending messages to the authorities and the public that more has to be done to ensure that our drugs are safe and effective.

Different countries are mandating various regulations for track and trace requirements. Manufacturers concerned that their products are at risk or have experienced product diversion or counterfeit infiltration are moving forward with efforts to prevent counterfeiting and diversion and improve recalls. They are doing so by implementing technologies, making organizational changes, and employing other methods to provide product authentication and security throughout the supply chain.

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Regulations
Pedigree requirements include documenting and tracking the entire chain of custody between trading partners. California’s Board of Pharmacy ePedigree law, scheduled to take effect in 2015, focuses on the electronic authentication of the “saleable unit” and ensuring that each product carries an electronic product code (EPC) that enables manufacturers to track every bottle or packet from the consumer to the provider and be able to trace it back to the specific lot in which it was manufactured in the plant. The state of Florida has implemented a pedigree law that requires paper pedigree documentation, as opposed to California’s ePedigree law that mandates an electronic pedigree.

In October 2011, the U.S. Food and Drug Administration published its final guidance on the use of on-dose anti-counterfeiting technologies (called physicochemical identifiers, or PCIDs) for use in solid oral dosage forms such as tablets and capsules.

According to the FDA, suitable PCIDs include inks, pigments, flavors, and molecular taggants; emphasizing that these ingredients should not be pharmacologically active so they can be treated from a regulatory perspective as inactive excipients. The smallest possible amount of a PCID to allow identification and authentication of a product should be employed to reduce the risk of side effects.

Similar regulations are sprouting globally from Europe to Brazil to China and India.

Best Practices and Approaches
The multitude of global regulations raises many key questions. How do pharmaceutical manufacturers comply with the multitude of international and global regulations? How can they standardize work processes, organizations, and technologies? Which approach should manufacturers deploy to meet these regulations: two-dimensional Datamatrix barcodes, linear barcodes, quick response (QR) codes, unique random or sequential serialization, or some other approach?  What types of track and trace systems work best for different companies, organizations, trading partners, and products? How do manufacturers synchronize their technologies with various government databases? Should they use a multi-faceted approach? Should authentication include the product, rather than just the packaging or both? What kind of authentication should they use? And what is the best technology for the product or manufacturing process or patient? ARC analysts are working to help their clients find answers to these, and other, important questions relative to supply chain integrity.

Janice Abel, jabel@arcweb.com, is Principal Consultant at ARC Advisory Group in Dedham, Mass.

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