Rx-360 Responding to the Threat of Illicit Medicines: Methodologies for Monitoring, Investigation & Stakeholder Engagement

The distribution and sales of illicit products such as counterfeit, unapproved and diverted medicines 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. This document provides 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 illicit medicines in the supply chain. Considering that patient safety is the priority for industry, pharmaceutical manufacturers should have a process dedicated to the identification and prevention of illicit medicines in the marketplace.

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