Protecting Product from Plant to Patient

While there are a number of technologies to combat counterfeiting and diversion, a comprehensive system that provides protection of the product itself is required.

Patients place an incredible amount of trust in the pharmaceutical industry that the medications they are taking are indeed the exact medications prescribed by their physician. When a physician puts pen to pad, he or she is also not usually wondering if the medication to be dispensed is real or counterfeit. At least, it has not been a pervasive thought until recently, as both the threat and the reality of counterfeit medications has risen with each passing day.

Of course, not all integrity issues are the result of counterfeit medications. Diversion plays an important role in the demise of the pharmaceutical supply chain as well. The loss of profits is an obvious result of diversion activities but the problem goes beyond lost profits and in fact is much more than a manufacturers' problem. Illegal diversion often serves as the catalyst for counterfeit product being inserted into the legitimate supply chain.

With an estimated $40 billion in counterfeits and perhaps an equally significant amount of diverted product entering the pharmaceutical supply chain each year, the stakes are high for the criminals who make large profits selling counterfeit medicine, as well as for consumers who are exposed to illegitimate, and at times dangerous, medicines.

The ideal protective solution is a multi-layered approach incorporating overt, covert, on-package and on-dose technologies, which when combined, protect products and patients.

More security needed

Traditionally, manufacturers have focused on securing product through package technologies; however, while these solutions provide a strong first level of defense, the cost of many medications has given counterfeiters significant motivation to attempt to copy any on-package technology. For example, counterfeiters have become adept at copying virtually all elements of pharmaceutical packaging, including boxes, bottles and even blister packaging.

While necessary tools in the fight against counterfeits and diversion, on-package technologies, including e-Pedigree initiatives such as 2D barcodes and RFID, fall short of a complete solution in that they are applied to the package only. Once a product is repackaged, even legitimately as in the case of dispensing by a pharmacist or via parallel trade, the protection provided by these on-package technologies is lost, as is the ultimate security of the product.

In order to better thwart counterfeiters and diverters, protect patients, and thereby raise the pharmaceutical supply chain to a higher level of integrity and confidence, manufacturers need to extend security efforts to on-dose (tablet, capsule, or vial) technologies.

NanoGuardian's NanoEncryption technology is the only on-dose, multi-layered, brand protection technology that enables manufacturers to trace and authenticate every single dose. NanoGuardian's NanoEncryption technology possesses intrinsic layered security features at the overt, covert and forensic level and is applied directly to tablets, capsules and vial caps. These multi-layered security features provide a dual-protective benefit to manufacturers with a single technology. The overt and covert security features enable authentication at any point in the supply chain, while the forensic-level NanoCodes provide comprehensive tracing information on each and every dose. 

NanoGuardian's NanoCodes can be associated with an unlimited amount of data, including but not limited to, product information, manufacturing information and distribution information. Since NanoEncryption technology always remains with the specific dose, even after numerous repackaging efforts, it provides brand integrity, protection, and confidence that traditional, on-package technologies cannot alone provide.

Manufacturers needs to implement protective strategies to combat criminals who reap profits by deceiving patients and in so doing, tarnish the reputation of safety and quality that they have worked so hard to achieve. On-package technology initiatives are a must of a comprehensive brand protection strategy; however, they become ineffective when product is repackaged. This gap in protection can often provide counterfeiters and diverters with the opportunity they need. Thus, a final step is needed to close this critical void and on-dose technologies such as NanoGuardian's NanoEncryption technology can provide the protection required for manufacturers to protect the supply chain from plant to patient.

Dean Hart serves as Executive Vice President of NanoGuardian, a division of NanoInk, Inc. A pharmaceutical industry veteran with over 25 years of experience, Hart most recently served as Senior Vice President Sales at Takeda Pharmaceuticals North America, where he led a sales force numbering in excess of 2500 in successfully meeting sales and profit goals.