Supply Chain Security White Paper: Prevention of Re-use of Genuine Packaging Components for Counterfeit Products
Ensuring the secure return and destruction of expired or waste pharmaceutical products and packaging is a key component of creating a secure supply chain. The illicit retrieval and reuse of pharmaceutical products and packaging can lead to fraudulent re-selling and diversion. Genuine packaging components that have been discarded can be retrieved and reused to disguise counterfeit product. Intact vials can be refilled with water or powders similar enough to the genuine products to convince the patients or caregivers that the product is genuine. In some cases, lower strength products may be re-packaged into higher strength product packaging in a process known as “up labeling”. All of these scenarios present potential risks to patients.
Genuine packaging components, with original labeling, valid lot numbers, valid serial numbers, and perhaps including overt and covert security features, are highly coveted by counterfeiters. By putting fake or substandard medicines into discarded genuine packaging components, illicit traders have a better chance of reintroducing that product into the legitimate supply chain. At the same time, it makes it much harder for healthcare professionals and/or brand owners to detect the fakes before they reach patients.
This white paper will look at means of mitigating the risks of re-used or re-purposed genuine product and / or packaging coming into the hands of illicit traders. It will review processes for securing the supply chain both upstream and downstream of manufacturing. It will also discuss technology options as means of mitigating this risk.