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 assessment

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

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

Preparation

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

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