The manufacture and handling of hazardous medicinal products (HMPs) pose significant safety and health risks to workers due to the potential for contamination and exposure. These products, often used in chemotherapy, antiviral treatments and other critical therapies, can have harmful health effects if not properly managed.
A European Commission (2021) study identified nurses as the largest single occupational group exposed to HMPs, comprising 40% of those affected, followed by technicians (11%) and pharmacists (9%). Traditionally, there has been a focus on the exposure of pharmacy staff due to the high concentration of HMPs in preparation.
However, it is now more urgent than ever to shift the focus to prevention and on the protection from occupational exposure of cancer nurses who deliver HMPs in outpatient and inpatient settings. Exposure to HMPs can result in a range of acute and chronic health issues, and can have a significant life-changing health impact. The European Commission (2021) estimates that, in Europe, about 7.3 million nurses are potentially affected by exposure to such dangerous substances every year.
A white paper, published last April by the European Biosafety Network (EBN) (Lindsley, 2024), has a crucial role in advocating for the implementation of closed systems in the manufacture and use of HMPs to protect workers from these risks.
‘Despite the challenges of implementation, such as cost, training and maintenance, the benefits of closed systems are clear and they should be used in the whole lifecycle of HMPs from manufacture to disposal’
In addition to preparing the paper, the EBN has worked with the European Trade Union Institute (ETUI), which has published an extensive list of the HMPs available in Europe (Lindsley and Musu, 2022). The list is based on the legal definition of HMPs as set out in European legislation that has been in force since 2022. HMPs are products described as containing one or more substances that meet the criteria for classification as category 1A or 1B carcinogens, mutagens or reprotoxins, which can cause severe health effects (Lindsley, 2024).
Common examples of such substances include certain chemotherapeutic agents, antivirals, hormones, immunosuppressants and bio-engineered drugs. Given their hazardous nature, it is imperative to handle these agents with utmost care to prevent worker exposure, whether through direct contact, inhalation or ingestion.
Benefits of closed systems
By fully containing HMPs during their manufacture, transport, preparation and administration, closed systems significantly reduce the risk of worker exposure.
Many regulatory bodies, including the European Agency for Safety and Health at Work (EU-OSHA) and the National Institute for Occupational Safety and Health (NIOSH) in the USA, recommend or require the use of closed systems for handling hazardous drugs, ensuring compliance with these regulations. Despite the challenges of implementation, such as cost, training and maintenance, the benefits of closed systems in reducing exposure to HMPs are clear and they should be used in the whole lifecycle of HMPs from manufacture to disposal.
In conclusion, closed systems in manufacturing and administering HMPs are not just critical strategies for protecting workers from contamination and exposure, but they also hold the promise of a safer future. By fully containing these substances, closed systems enhance safety, ensure regulatory compliance and improve operational efficiency.
As the pharmaceutical industry advances, adopting closed systems will play an increasingly vital role in safeguarding worker health and maintaining safe working environments. Implementing closed systems is not merely a regulatory or legal requirement but a moral imperative to protect those who work tirelessly to produce and administer life-saving medications.