Hazardous non‐cytotoxic medicines: uncertainty around safe handling? A new workplace guideline for hospital staff

Abstract

Hazardous medicines have the potential to cause harm via occupational exposure. We describe the development of a guideline to clarify the risks of occupational handling of non‐cytotoxic hazardous medicines, and provide practical advice for frontline staff in the hospital setting. Nurses and pharmacists in Victorian hospitals were surveyed to capture their experience, whilst a literature review located 14 national or jurisdictional guidance documents. Nurses and pharmacists reported variance in practices when handling an example medicine (mycophenolate). Many found existing guidance around hazardous non‐cytotoxic medicines unclear or confusing. Medicines were categorised into four groups: cytotoxic medicines; hazardous non‐cytotoxic medicines; medicines that primarily pose a risk to men and women actively trying to conceive and women who are pregnant or breastfeeding; and medicines that are irritants to mucous membranes or airways. An institutional guideline was developed, with recommendations synthesised into a single‐page chart for quick reference at the point of care.

Standard of practice in oncology and haematology for pharmacy services

“…The preparation and administration of non-cytotoxic and/or hazardous cancer therapies must additionally adhere to the local policy, which may be informed by consensus guidelines. 24,27 The compounding service should have a process of releasing compounded medicines that is compliant with existing guidelines. 8 The pharmacist must liaise with the relevant pharmacy staff, or external manufacturer, to ensure there are adequate medicine stock levels for the oncology and haematology service.…”

“…Health and safety precautions must be followed to minimise the risk of exposure. 24,8,30 When a defined course of therapy is prescribed, it is recommended the exact quantity for a course of oral cancer therapy is issued, as opposed to whole packs. This decision must be based on the judgement of pharmacists experienced in cancer therapies, including cytotoxic and non-cytotoxic hazardous medicines, and may depend on local/state policy.…”

Standard of practice in clinical trials for pharmacy services

“…Guidelines for handling cytotoxic medicines and/or targeted therapies should also be adhered to when applicable. [22][23][24]25…”

“…When handling returned investigational products, in particular oral cytotoxic and other hazardous medicines, gloves should be worn and counting devices cleaned after each use as per relevant local guidance. 22,23,25,27 Transfer/Distribution to other Institutions…”

“…This is in addition to the Australian Code of Good Manufacturing Practice for Medicinal Goods‐Investigational Medicinal Products, 16 in particular Annex 13 ‐ Manufacture of Investigational Medicinal Products. Guidelines for handling cytotoxic medicines and/or targeted therapies should also be adhered to when applicable 22‐24,25 …”