Counterfeit, Unapproved and Diverted Drugs Threats & Monitoring Process

Introduction and Overview:

The distribution and sales of Counterfeit, Unapproved and Diverted Drugs (CUDD) are a global concern for pharmaceutical patients, health care professionals, regulators and manufacturers. Counterfeit drugs are not equivalent to the genuine product in safety, efficacy and quality. At best, they are of unknown composition and may be ineffective, and at worst harmful to patients. Unapproved medicines are drug products that have not been approved by a country’s health authority for product quality and efficacy or patient safety. Diverted drug products may be genuine but may not have the properties that doctors/pharmacists expect (if they are imported products) and may be subject to mishandling and inappropriate storage conditions that may impact product quality. They typically contain packaging and information leaflets in foreign languages for foreign markets that are not approved by the local health authority, and are considered misbranded. Considering that patient safety is the priority for industry, pharmaceutical manufacturers should have a process dedicated to the identification and prevention of CUDDs in the marketplace.

This document provides a general overview of the definitions, sources, and distribution of CUDDs in the finished form, as well as a high level summary of Supply Chain Security (SCS) monitoring practices and tools that pharmaceutical companies can use to help detect, deter, and to establish appropriate control for CUDDs in the supply chain. It also refers to the concept of a Management System Maturity Model: a concept being introduced by the Rx-360 Supply Chain Security (SCS) initiative. A Maturity Model will be used in subsequent versions of this document to drive the measurable and sustainable improvement of SCS toward a comprehensive Management System. This document is meant to provide a basic understanding but does not seek to provide detailed guidance.

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