Editorial ArticlePrecautions, perspectives, and practicalities: the reality of safe handling of hazardous drugs in hospitals
Guidance for the management of hazardous medicinal products at work
In 2021, it was estimated that almost 1.8 million workers were exposed to hazardous medicinal products (HMPs); these are medicinal products that contain one or more carcinogenic, mutagenic or reprotoxic substances.1 Routine exposure to such substances can have a negative effect on workers, causing adverse health effects such as chromosomal abnormalities, alterations to blood cell counts, and increased risk of cancers.1
This year, the European Commission released guidance for the safe management of HMPs at work, underpinned by EU legislation.1 The guidelines promote increased awareness and good practice of HMPs for those handling them.1 This article provides an overview of the guidance, focusing on the areas that will affect healthcare professionals regularly working with HMPs.1
Exposure to HMPs can occur through inhalation, ingestion and the skin.1 Dermal exposure is the key exposure route in hospitals and pharmacies, due to contact with contaminated workplace surfaces, and can result in systemic and local effects.1 It is the responsibility of the employer to frequently assess exposure to HMPs to capture any potential increase in exposure via workplace monitoring, biomonitoring, or a combination of both.1
Workplace monitoring of HMPs is mostly performed by surface wipe sampling; air monitoring is utilised when airborne particles are expected due to the preparation and administration of HMPs.1 Alternatively, biomonitoring assesses workers’ exposure by analysing HMPs and/or their metabolites in their bodily fluids.1
Workers must be informed about the monitoring plan, the results, personal consequences, and follow-up actions, but the actual monitoring should be unannounced to avoid biased results.1
Health surveillance is a scheme of repeated health checks for the monitoring and counselling of workers who come into contact with HMPs.1,2 This surveillance detects changes in workers’ health status that may be attributed to their exposure, such as detecting early and reversible signs of occupational disease.1 The frequency of these health checks is dependent on the individual’s role and personal risk level; for example, immunosuppressed individuals may be classed as high-risk and therefore require more frequent health checks.1
Generally, those identified as high-risk require annual health surveillance, medium-risk individuals require biennially and low-risk triennially.1
A medical practitioner collects baseline data prior to an individual’s exposure to HMPs, subsequent health checks are then undertaken at regular intervals.1 If abnormalities are identified a follow-up plan should be created for workers.1 Workers must have access to their results and should keep copies for their own records.1
It is important that health surveillance is evaluated annually in the context of workplace monitoring to check exposure levels and identify adjustments to the programme, where necessary.1
A confined area for authorised personnel is required for the preparation of HMPs; however, there are scenarios where preparation at the administration area is unavoidable.1 In this scenario, a risk assessment is needed to determine the required measures.1
The confined area for preparation should be externally vented and include appropriate equipment for the safe preparation of HMPs, such as a biological safety cabinet for the weighing, crushing, and mixing of tablets, which can generate airborne particles.1
Personal protective equipment (PPE) should be worn during the preparation of HMPs to significantly reduce the incidence of adverse health effects.3 At the very least protective gloves type B, protective face shield/goggles, protective gown/coveralls and respiratory protection are needed during preparation.1
Administration should be centralised in a dedicated area and, where possible, patients should self-administer.1 As for injections and intravenous (IV) infusions, where self-administration is not possible, technical measures can be implemented such as the use of a Luer-lock, instead of a Luer-slip connection, to reduce slippage and leakage.1
In addition to technical measures following standard operating procedures, hygiene measures, effective cleaning, PPE and the proper disposal of waste can help to reduce exposure.1 Remember to be mindful that while a patient is treated with HMPs, and for 7-14 days afterwards, their excreta and blood should be treated as contaminated with HMPs.1
Employers have a responsibility to protect their workers from risks to their health and safety.4 It is of the utmost importance that both employers and employees make every effort to ensure the safety of themselves and others, as failure when handling HMPs can result in irreversible harm.3
1. European Commission. Guidance for the safe management of hazardous medicinal products at work.; 2023. Available at: https://osha.europa.eu/sites/default/files/KE0322175ENN_0.pdf. Accessed September 21, 2023.
2. Health and Safety Executive (HSE). Health surveillance. Available at: https://www.hse.gov.uk/health-surveillance/overview.htm. Accessed September 21, 2023.
3. Ehmke N. Safe Handling of Hazardous Medications – CE.; 2020. Available at: https://www.elsevier.com/__data/assets/pdf_file/0015/1002318/Safe-Handling-of-Hazardous-Medications-Skill-COVID-19-toolkit_140420.pdf. Accessed September 21, 2023.
4. Health and Safety Executive (HSE). Health and safety at work: criminal and civil law. Available at: https://www.hse.gov.uk/simple-health-safety/law/health-safety-law.htm#article. Accessed September 21, 2023.