The document discusses risks associated with prescribing and handling unlicensed medicines. It identifies key risks such as lack of appropriate formulations, dosing difficulties especially for pediatrics, uncertainty around how to dose or monitor new unlicensed drugs, potential administration and monitoring issues, and lack of product information due to foreign language labels. It also discusses risks related to the supply chain including regulatory compliance, quality of the supply, and potential for deception or counterfeiting if intermediaries without proper licenses are used. The document recommends pharmacists conduct risk assessments to evaluate what is known about adverse events and interactions of the unlicensed medicine, how it will be sourced, and the reliability and regulatory compliance of suppliers.

1. Mind your step: Identifying risk with unlicensed medicines Dr Simon Letellier Deputy hospital pharmacist Niort general hospital France EAHP ICT groups Satellite Symposium Navigating Risk Management 28 february 2008

2. 1- Introduction Risk : “ The uncertainty of an event / hazard occurring that could have an impact on the achievement of objectives. Risk is measured in terms of consequences and likelihood . ”

4. 2 – Risks for prescribing and handling : the specific risks

10. Possible risks areas of drugs product development and distribution Substitution (counterfeit) Fraud Disguise Drug theft Diversion Deception Fraud Sell drug to grey market Drug counterfeits Product diversion/theft Fraudulent labels label switching repackaging Cutting product with counterfeits

11. 3 - Pharmacist’s role Risk Assessment Quality Assurance Risk reduction What can pharmacists do to help minimise risk?