Hazardous Medicinal Products (HMPs)
What are HMPs
HMPs are defined as hazardous medicinal products that contain one or more substances that meet the criteria for classification in accordance with Regulation (EC) No 1272/2008 (the CLP Regulation):
- Carcinogenic (category 1A or 1B)
- Mutagenic (category 1A or 1B)
- Toxic for reproduction (category 1A or 1B)
This includes medicinal products for both human and veterinary use.
Health Effects
Exposure to HMPs can cause unintended effects in workers that are exposed to them. HMPs can cause carcinogenic, mutagenic or reprotoxic (CMR) effects in exposed workers. A range of other adverse health effects are also associated with exposure to hazardous medicinal products including miscarriages/impaired fertility, cancers, respiratory problems, hair loss, loss of taste and various types of infection.
Control of exposure
New EU guidance has been published for the safe management of HMPs at work. https://ec.europa.eu/social/main.jsp?langId=en&catId=89&furtherNews=yes&newsId=10564
This guidance provides information in relation to the potential exposure, handling, good practice and control measures with respect to HMP’s throughout their lifecycle from manufacture through to disposal.
Exposure can affect workers throughout the lifecycle from manufacturing through transport to medical workers as well as cleaners, laundry and workers involved in waste disposal. The advice provided in the guide is tailored to the groups of workers potentially exposed.
The EU Commission plan to publish a list of HMPs by April 2025. In the interim, the European Trade Union Institute (ETUI) have published their own list https://www.etui.org/publications/etuis-list-hazardous-medicinal-products-hmps and employers who handle HMPs for identification and risk assessment purposes should consult this list.
Legislation
The Safety, Health and Welfare at Work (Carcinogens, Mutagens and Reprotoxic Substances) Regulations (2024)
The Safety, Health and Welfare at Work (Carcinogens, Mutagens and Reprotoxic Substances) Regulations S.I. No. 122 of 2024 (irishstatutebook.ie) have come into effect on the 5th April 2024. These new regulations consolidate the 2001 Carcinogens regulations along with its amendments in 2015 and 2019.
The Chemical Agents Code of Practice 2024 https://www.hsa.ie/eng/publications_and_forms/publications/codes_of_practice/chemical_agents_code_of_practice_2024.pdf for the Safety, Health and Welfare at Work (Chemical Agents) Regulations (2001-2021) & the Safety, Health and Welfare at Work (Carcinogens, Mutagens and Reprotoxic Substances) Regulations (2024) has also come into effect.
The 2024 regulations along with the Code of Practice have transposed Directive (EU) 2022/431 which is the fourth update to Directive 2004/37/EC (Carcinogens and Mutagens Directive (CMD)). This Directive brings reprotoxic substances under its scope and introduces hazardous medicinal products (HMPs).
Workers exposed to hazardous medicinal products (HMPs), or hazardous drugs, which are carcinogenic, mutagenic or reprotoxic substances (CMRs), must be given specific training by their employers to prevent risks of adverse effects on their health. This training should cover the potential risk to health, the precautions to prevent exposure, the hygiene requirements, the wearing and use of personal protective equipment, the steps to be taken in the event of an incident, and the significance of the labelling, warning and hazard signs in relation to installations and containers containing carcinogens, mutagens or reprotoxic substances. The training has to take into account any new or changed risk. This training has to be provided on a regular basis when workers are likely to be exposed to carcinogens, mutagens or reprotoxic substances including those contained in hazardous medicinal products.
Further information
