Healthcare workers will be protected from hazardous drugs by an EU law which had to be transposed by member states by today.
From today, millions of workers, most of them women, will be protected by European Union and national law from the impact of regular exposure in the workplace to potentially life-threatening hazardous drugs—the hazardous medicinal products (HMPs) used to treat patients with cancer and other major health conditions.
The European Biosafety Network has today published a white paper, setting out the requirements of the new EU law for employers and national governments and what it means in practice for millions of workers and professionals engaged in healthcare, social care and veterinary practice.
Nurses are by far the largest occupational group affected, with 40 per cent exposed to HMPs, followed by technicians (11 per cent) and pharmacists (9 per cent), according to a study by the European Commission in 2021. Yet nurses are usually less likely to be protected than pharmacists—even though more than four times as likely to be exposed.
Studies show that hospital workers who handle HMPs are as a result three times as likely to develop malignancy and nurses exposed to cytotoxic drugs are twice as likely to miscarry. Patients, visitors and family members can be exposed just by contact with contaminated work surfaces, clothing or medical equipment and many patients are now treated at home rather than in a hospital.
HMPs cannot usually be eliminated or substituted because of their vital therapeutic roles. But occupational exposure to HMPs can have significant health impacts on workers, including cancer, leukaemia and miscarriages. The European Trade Union Institute (ETUI) estimates that up to 12.7 million workers in healthcare, social care and veterinary practice are at risk of exposure across Europe.
Closed systems
In March 2022, the EU confirmed that HMPs were included in the scope of the directive then adopted on carcinogens, mutagens and reprotoxic (CMR) substances. Member states were required by today to transpose all its legal requirements and prevention measures into national legislation.
The directive means that now, following a risk assessment, HMPs must be manufactured and used in a closed system, to reduce and prevent contamination and exposure for workers and professionals. A closed system in healthcare means biological safety cabinets (BSCs), containment isolators and closed-system transfer devices (CSTDs), especially those with a physical barrier.
Isolators and BSCs are effective in preventing contamination and occupational exposure in the preparation of HMPs in the pharmacy, while CSTDs are effective across the whole life-cycle of HMPs and all therapeutic groups—in particular, in the administration of HMPs on the wards. Needles, syringes, spikes, vials and bags are not designed to isolate the HMPs they manipulate and are thus less safe when so used.
Hospital pharmacists believe that CSTDs offer the most effective way to protect workers from potential exposure to HMPs, including when used in combination with BSCs and isolators. CSTDs are proven to reduce exposure to HMPs and should thus be used throughout their life-cycle.
Safe management
In April last year the European Commission published guidanceon the safe management of HMPs at work. This was broader and more holistic than its EU, national or local predecessors and innovative in recommending prevention measures extending to all types of organisation and all stages throughout the HMP life-cycle, from manufacture to disposal.
An ETUI report published six months earlier had provided a list of HMPs. It remains the only one to identify those falling under the scope of the 2022 CMR directive. So employers and workers know to which particular HMPs EU and national law, and the EU guidance, now apply, requiring the use of closed systems.
The ETUI list is based on the legal definition of HMPs in the directive, replicated in the 2023 commission guidance. HMPs contain one or more substances that meet the criteria for classification as category 1A or 1B CMR set out in annex VI to the 2008 EU regulation on the classification, labelling and packaging of substances and mixtures (1272/2008).
Deserving of protection
Automation and robotics in the compounding and preparation of HMPs is revolutionising safety, quality and efficiency in handling them and preventing occupational exposure. It is still not however widely adopted, as it needs to be.
Healthcare workers potentially put themselves at risk every day by doing their job of treating patients and they deserve our protection to avoid life-changing health impacts. This new EU law can give them that protection and must be implemented in full, to protect those who care for all of us.
