Identification and risk assessment of hazardous medicines

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A significant number of medicines can pose a health and safety risk as a result of unintended exposure when people other than the patient — such as carers, family members or healthcare professionals — handle them.

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Pharmacists have a responsibility to inform consumers, carers, and healthcare professionals who handle medicines about ways to manage the potential risks associated with a medicine.
In addition, healthcare facilities such as hospitals and aged care facilities have a legal responsibility and obligation to protect their staff from occupational exposure to hazardous substances. This responsibility requires these facilities to:

• identify potential hazards in the workplace


• assess the risks associated with the potential hazards


• eliminate or minimise the risk associated with the potential hazards


• maintain and review risk control measures

The latest edition of the Australian Pharmaceutical Formulary and Handbook (APF23) provides an invaluable tool for pharmacists, healthcare professionals and hospital administrators in regards to identifying and making an assessment of hazardous medicines
APF23 provides a convenient source of practical, current, evidence-based information to assist pharmacists and can be used to quickly find information and guidance on many areas of pharmacy theory and practice, including identifying drug-related issues; making clinical judgements; counselling consumers on the safe and effective use of their medicines; and preparing extemporaneous products or modified oral formulations.
It is a Pharmacy Board of Australia recommended reference text for all pharmacists.
To help protect people from unintended exposure to hazardous medicines, APF23 contains a list of hazardous medicines that are recommended to be labelled with Cautionary Advisory Label 21 (special handling and disposal required – ask your pharmacist).
An issue for the Australian health environment is the variation across the country in State and Territory approaches including those in place for local clinical governance, work practices and jurisdiction requirements. This presents particular challenges when developing PSA’s Cautionary Advisory Labels (CALs). CALs are an important counselling tool used by pharmacists but they need to be used in an appropriate and targeted manner.
To ensure relevance and appropriateness of CAL recommendations, the Cautionary Advisory Label Working Group reports to the APF Editorial Board and is charged with reviewing the CALs using the latest available evidence and manufacturers’ and regulatory documentation, while also examining safety and clinical relevance.
In view of jurisdictional differences across the country and the different ways in which people can be exposed to hazardous medicines, the counselling and cautionary advisory labels chapter of the APF emphasises that pharmacists are expected to exercise professional judgement when deciding whether to omit one or more cautionary advisory labels for a particular patient.
The chapter contains extensive explanatory notes about the appropriate use of CALs. The intent of the explanatory notes is to assist pharmacists in the decision-making process associated with using CALs. The APF list of hazardous medicines assists pharmacists to identify medicines that pose a potential risk, and is a prompt to inform consumers, carers and healthcare personnel. Once a potentially hazardous medicine has been identified, the pharmacist or healthcare facility can assess the level of risk associated with the medicine in the context of how it is to be handled (such as self-administered by the patient intact or crushed by a staff member).
Using the criteria for hazardous medicines outlined in APF23 helps pharmacists and healthcare facilities to identify and assess the potential risks associated with medicines that may have limited safety data. Selectively removing a medicine or class of medicines that meets one of the criteria for inclusion in the list may have legal ramifications to the pharmacist or healthcare facility should an adverse outcome occur.
Assessment of the risk associated with inadvertent exposure of carers or healthcare facility staff should consider factors, such as:

• the potential route/s of entry of the medicine


• who could be exposed to the medicine (e.g. pregnant staff members)


• when exposure is likely to occur (e.g. during administration of the medicine)

After consideration of the risk associated with exposure to a medicine, pharmacists or healthcare facilities can then determine appropriate strategies to eliminate or minimise risk, which may include the use of gloves, eye goggles, face masks and so on.
The Counselling and cautionary advisory labels chapter also reminds pharmacists that CALs are a tool for pharmacists to use as an aid to counselling and are intended to reinforce rather than replace verbal counselling. As an example, Label 21 is not intended to provide specific information to consumers about handling requirements for medicines. Rather, it is used as a prompt for consumers to discuss with the pharmacist any handling requirements that may be relevant to the particular patient.
he importance of identification and risk assessment of hazardous medicines has been underscored by the Chair of the APF23 Editorial Board, Emeritus Professor Lloyd Sansom, who has stressed that unintended exposure to a hazardous medicine during preparation and administration could occur through skin contact, ingestion or inhalation and some people, such as pregnant women, may be at greater risk from unintended exposure than others.
“Some hazardous medicines may not pose a significant risk if they are administered to patients intact, (that is via coated tablets, capsules), but the risk can be increased if these formulations are modified (e.g. cutting, crushing, or opening capsules), or with long-term, low-level exposure,” he said.
Oral products of hazardous medicines should be swallowed whole where possible, and should not be removed from their original packaging for transfer into a dose-administration aid. Standard operating procedures should be developed by institutions to minimise risk.
“APF23 recommends patients and their carers are made aware of the risks of hazardous medicines and the precautions that can be used to minimise risk of exposure, including the use of gloves, face masks and non-permeable gowns,” Professor Sansom said.
“There is limited data available on exposure limits for individual medicines identified as being hazardous. The APF provides general guidance, but this may not be applicable to all possible scenarios encountered in practice. Pharmacists are advised to conduct their own risk assessment to determine the appropriateness of labelling and handling requirements in specific circumstances.

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“Cautionary advisory labels are an important counselling tool for pharmacists.”

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Grant Kardachi
Grant Kardachi was recently re-elected president of the Pharmaceutical Society of Australia for a fourth term. He is a community pharmacist who recently sold his business interests but is still accredited to undertake medication reviews and sits on the Australian Association of Consultant Pharmacy.