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Introduction


Safe handling of hazardous drugs


Hazardous drugs are used to treat non-malignant as well as malignant diseases, and include cytotoxics, biological agents, hormones and anti-viral agents. The risks to patients and healthcare professionals in their handling are considered in this review


Burhan Zavery BPharm MSc Pharmacy Department Mid-Cheshire Hospitals NHS Foundation Trust, Middlewich Road, Leighton, UK


All drugs are harmful, with an individual drug’s benefit, indication and use determined by the balance of its effect and side-effects on the patient. Hazardous drugs are drugs that pose an additional handling and exposure risk to healthcare professionals and members of the public, who may inadvertently come into contact with the drug. The National Institute for Occupational Safety and Health (NIOSH) alert 20041


defines hazardous drugs to


include the following six criteria: ● Carcinogenicity ● Teratogenicity or other developmental toxicity


● Reproductive toxicity ● Organ toxicity at low doses ● Genotoxicity ● Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria


2


Hazardous drugs are commonly used to treat malignant diseases, but increasingly in non-malignant diseases, too. These include cytotoxics, biological agents, hormones and antiviral agents. Most hazardous drugs are designed for parenteral administration. Cytotoxic drugs are inherently hazardous, due to their carcinogenic, mutagenic and teratogenic potential, requiring careful and safe handling to minimise occupational exposure of healthcare professionals. Monoclonal antibody drugs and other biological target drugs also


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pose a hazard risk including sensitisation risk. Similarly, continued exposure in the long term from some biosimilar drugs and antibiotics, for example, penicillins, can also result in sensitisation. It is known that antibiotics, in common with antivirals and bioengineered drugs, can interfere with cell growth or proliferation. In addition to the danger they pose in their own right, as their use increases, so does the risk to healthcare workers whose attitudes, understanding and perceived risks of antibody-resistant organisms may not be optimal. Koltes has highlighted, for example, that compliance with methicillin-resistant Staphylococcus aureus (MRSA) infection control precautions by healthcare workers remains dangerously low, resulting in the fact that they have a high risk of becoming colonised with MRSA, transmitting MRSA to others and acquiring MRSA infections themselves.2 The scale of the underappreciated occupational risk for healthcare workers who are receiving narrow-spectrum antibiotics (including cephalosporins, clindamycin and fluoroquinolones3


) from


Clostridium difficile is a source of growing concern.4


Given the increase in number of antibiotics preparations, the scale of the risk to healthcare workers can only increase.


Oral drugs pose a different kind of hazard risk, if crushed or broken, for example, for patients with swallowing difficulties such as paediatric and elderly patients.


It is important to note that investigational and experimental drugs are considered hazardous until proven otherwise.


Nature of hazard


Coming into contact with hazardous drugs can cause numerous problems to healthcare staff and members of the public.5 Acutely, exposure to cytotoxic drugs can irritate the skin, eyes and mucous membranes. Other acute effects reported include lightheadedness and nausea. These have primarily been reported in circumstances where control to exposure has been deemed inadequate. The risk is dependent on the nature of the drug and the level of exposure to the drug. Longer-term (chronic) exposure to cytotoxic drugs has reported significant increases in measures of genetic damage in workers handling these drugs compared to the reference population. This can lead to adverse reproductive outcomes (such as infertility and birth defects) and cancer.


Little is known about repeated exposure to low amounts of mutagenic and carcinogenic compounds, however the evidence points to the potential risks being considerable. Therefore, while there is acknowledgement that there are no safe limits of exposure, the aim should be to minimise and even eliminate exposure of healthcare professionals and the public to hazardous drugs.


Routes of exposure


The primary routes of exposure to hazardous drugs include:


● Dermal – Skin contact, for example extravasation and spillage risks


● Ingestion – Contamination of food and drink


● Inhalation – Breathing in aerosols or powder


Certain hazardous drugs are known to


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