Safe handling of hazardous drugs: applying the CMRD in Ireland

Exposure to a hazardous drug (HD) or hazardous medicinal product (HMP) can occur to any worker involved in any stage of the chemical’s lifecycle – from manufacturing and delivery, to patient administration and medication disposal.¹ While there is a greater awareness of the risks of HDs in professions such as pharmacy and nursing, during other stages of the chemical’s life cycle, worker awareness of potential dangers is lacking.¹

EU CMRD and guidance on the safe handling of hazardous drugs

In 2022, the European Union (EU) Directive 2022/431 for the handling of carcinogens, mutagens or reprotoxic substances at work (CMRD) amended EU Directive 2004/37/EC (CMD) to include HDs and reprotoxic substances.² The deadline for transposing the CMRD into national law in all EU member states, including Ireland, was 5 April 2024.² With an estimated 12.7 million workers across the EU risking HD exposure, the implications of the changes to the directive merit scrutiny.³

The European Commission has until 5 April 2025 to release an indicative list of HDs that are considered carcinogens, mutagens and reprotoxic substances (CMRs).³ To get users ready, the European Trade Union Institute (ETUI) drew up a list of 121 HDs that fall within the scope of the CMRD.³

In 2023, the European Commission published the ‘Guidance for the safe management of hazardous medicinal products at work’ in support of the CMRD.⁴ Aimed at workers who may be handling or exposed to HDs, the objectives of this document are to raise awareness on the risk of exposure to HDs, and encourage safe handling.⁴

Ireland prioritises hazardous drug safety

On 30 January 2024, Irish organisations responded to the CMRD with an educational summit hosted by Fórsa, the European Biosafety Network (EBN), the Hospital Pharmacists Association of Ireland (HPAI) and the National Association of Hospital Pharmacy Technicians (NAHPT) Ireland.¹

The joint summit was called to discuss the implications of the CMRD to Irish employers and employees.¹ Attendees were drawn, among others, from the spectrum of Irish health and social care, including hospital pharmacists, oncology nurses and occupational health specialists.¹

With more than 85,000 members, Fórsa is the largest public service trade union in Ireland.⁵ This trade union is made up of six branches, including the health and welfare branch.⁵ Since 2010, the EBN has been committed to improving healthcare worker safety and preventing the occupational exposure to HDs across the EU.⁶

As part of Fórsa, the HPAI is a voluntary organisation for Irish hospital pharmacists.⁷ Fórsa represents them and negotiates their pay and employment conditions.⁷  The NAHPT is Ireland’s voluntary association of hospital pharmacy technicians and was founded in 1997.⁸ One of its objectives is to share best practices.⁸

“Worryingly the results [of a survey of Irish workers conducted by EBN from January to July 2023] […] show a lack of awareness about the issue [of exposure to HDs] and low levels of risk assessments undertaken, coupled with insufficient training and a lack of preventive measures and surveillance of contamination,” said Ian Lindsley, Secretary of the EBN.^1,9

Next steps for Ireland

Following presentations and discussions, the summit delegates concluded that the current ‘Guideline on the Safe Handling of Cytotoxic Drugs,’ put out by the Irish Health Service Executive (HSE) in 2022, has not yet been updated to include the CMRD requirements for the safe handling of hazardous drugs.¹

Consequently, Fórsa, the EBN, HPAI and NAHPT strongly urged:¹

• The HSE to update the guideline mentioned above to comply with the CMRD
• The Irish Health and Safety Authority (HSA) to increase surveillance of healthcare and manufacturing sites which handle and produce HDs
• The HSE to adopt the ETUI’s list of HDs right away and at the national level

Darren Arkens, Senior Inspector in the Occupational Health Division of the HAS, explained that the HSA is fully committed to enforcing the CMRD and translating this directive into national laws and regulations to help ensure healthcare worker safety in Ireland.¹

To keep Irish law in step with the CMRD, the HSA had enforced the ‘Code of Practice 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’ as of 5 April 2024.^10,11

Recommendations for the safe handling of hazardous drugs

During the summit, Paul Sessink, Managing Director of Exposure Control Sweden AB, stressed the importance of carrying out regular risk assessments, conducting surface contamination monitoring and using closed system transfer devices (CSTDs).¹

Risk assessments

Close to 40% of respondents of the EBN survey mentioned above did not have a written policy for handling HDs or performing risk assessments.¹ Occupational safety and health officers are responsible for conducting risk assessments to determine adverse health effects at the assessed exposure levels.¹

Surface contamination monitoring

Under 33% of EBN survey respondents monitor for surface contamination of hazardous drugs.¹ It is essential that Irish employers implement surface contamination monitoring programmes that include wipe sampling to measure baseline contamination, compare contamination levels over time and determine the effectiveness of cleaning processes to improve the safe handling of hazardous drugs.¹²

Closed system transfer devices

Along with surface wiping and personal protective equipment (PPE), summit organisations also recommend the use of CSTDs when handling HDs.¹ To clarify the difference between primary engineering controls (PECs) (e.g., biosafety cabinets and isolators) and CSTDs, Dr Sessink explained that PECs help protect medications from microbial or chemical contamination, while CSTDs help protect healthcare workers from exposure to HD contamination and medications from chemical contamination.^1,13

CSTDs have been shown to significantly reduce contamination from HDs, while lowering the risk of exposure.¹⁴

The time to act is now

Linda Kelly, Fórsa National Secretary, said, “With the issue of exposure to HMPs directly and indirectly impacting so many of our members, it is imperative that awareness by employers and workers of the risks is improved and we act now to prevent the damaging health effects that exposure to HMPs can have on the workforce.”¹

More on this topic: EU Directive 2022/431: What’s in it for healthcare workers?

References