Safe management of hazardous medicinal products at work

For the purposes of this guide, hazardous medicinal products (HMPs) are defined as medicinal products that contain one or more substances that meet the criteria for classification as:

• Carcinogenic (category 1A or 1B),
• Mutagenic (category 1A or 1B) or
• Toxic for reproduction (category 1A or 1B)

in accordance with Regulation (EC) No 1272/2008 (the CLP Regulation)

This includes medicinal products for both human and veterinary use.

By virtue of the working definition given above, HMPs fall within the scope of Directive 2004/37/EC (the Carcinogens, Mutagens and Reprotoxic Substances Directive, CMRD) .

HMPs include some antineoplastics, immunosuppressants, antiviral medicines, and others.

HMPs are used to treat a wide range of medical conditions including cancer treatment and rheumatology.

HMPs can cause unintended effects in people other than the patients themselves, such as the workers who are exposed to them.

This guide aims to:

• Increase awareness about the risks of hazardous medicinal products amongst the workers that might come into contact with or handle HMPs and their employers
• Increase good practice by workers handling HMPs across the EU and provide a useful reference point and support for training activities
• Improve the flow of information about HMPs as they pass between the different life cycle stages in their supply chain
• Promote harmonization between Member States and sectors by ensuring comprehensive guidance is available to all stakeholders.

There are some existing guides covering the use of HMPs, but they are often written at a regional or local level, or only cover parts of the life cycle or specific roles.This guide

• Should reduce this fragmentation of guidance about HMPs
• Be a flexible up-to-date tool which can be revised in the future, responding and adjusting to pharmaceutical advances

This guide focuses on preventing and controlling risks from occupational exposure to HMPs and the information contained therein does not constitute a comprehensive overview of procedures for ensuring patient safety.

The information in this guide must be read in conjunction with legislation and protocols for ensuring patient safety.

We attach de full text of the Guide, published by the European Commission.