Pharmaceutical & Medical Packaging News: Tracking & Tracing

Guest Editorial

Guest Editorial,

Continued from page 5

the significant profits available have given counterfeiters strong motivation to replicate virtually all elements of pharmaceutical packaging including boxes, bottles, and even blister packaging. Often, the “fakes” are so convincing that only those responsible for product packaging can detect the subtle differences, which further adds to the deception of supply-chain partners, healthcare professionals, and patients.

In addition, most if not all on-package brand protection technologies become ineffective when a product is repackaged. This process occurs the vast majority of the time in the U.S. pharmaceutical supply chain and remains supported by the EU in the environment of parallel trade.

With the most important participant in the supply chain being the patient,

on-package brand protection being less than a total solution, and the downstream supply-chain technology and informatics needed to make e-pedigree

In this threatening

environment,

pharmaceutical

manufacturers need to

establish protective

strategies that have an

immediate impact in

combating criminals.

initiatives a reality years away, on-dose brand protection technologies are required for manufacturers to protect the supply chain from plant to patient.

The pharmaceutical supply is under attack by unscrupulous individuals who seek to profit with complete disregard to the health of patients. Ultimately, it is the manufacturer’s product and the health of the patients they serve that are most at risk. As such, manufacturers shoulder the burden to implement protective measures that thwart counterfeiters and diverters, protect patients, and thereby raise the pharmaceutical supply chain to a higher level of integrity and confidence. Manufacturers must also realize that the enemy in this war is highly motivated, connected and resourced. Traditional methods of brand protection, while still valuable, are waning in benefit. It is a new-age battle that requires manufacturers to fight with everything at their disposal, including state-of-the art technologies that protect the integrity and therapeutic benefit of each and every dose.

Editorial,

Continued from page 4

back into his pharmacy’s drug supply. He had told these unwitting providers that he was collecting the drugs as part of a humanitarian mission to underdeveloped countries.

The California State Board of Pharmacy also discussed a letter from Kaiser Permanente’s Steve Gray. This pharmacist has asked for the board’s help in requiring common carriers like FedEx, UPS, and DHL to deliver pharmaceutical shipments directly to pharmacists, rather than leaving the shipments at unloading docks in the hands of personnel unlicensed to handle prescriptions. This request (apparently his second or perhaps even his third) reveals the very danger that threatens the pharmaceutical supply chain—the lack of continuous visibility of how and where products are handled.

Clearly, counterfeiting and diversion are still threats. And the criminals are getting craftier.

How should you protect your products throughout the supply chain? It may even be a global supply chain, given the globalized nature of commerce today, so perhaps the question is: how can you protect products as they loop around the world?

It is not an easy proposition. FDA is looking closely at unqiue product identification; for drugs, it has suggested the use of a serialized National Drug Code (NDC). Other governments around the world, too, are looking at serialization. Duplicate serial numbers will certainly help wave red flags. But can the U.S.-centric NDC be serialized so that it provides worldwide identification and therefore worldwide protection?

The other big question is, will unique autoID be enough? What

role could packages filled and sealed by manufacturers (or their contract packagers) play in assuring patients of product integrity through minimal product handling? With a few pharmacists tangled up in counterfeiting and diversion, why leave patients wondering about the source and path of their medication?