What is Biological/Immunological Therapy?
Biological therapy involves the use of living organisms, substances derived from living organisms, or laboratory-produced versions of such substances to treat disease. Some biological therapies for cancer use vaccines or bacteria to stimulate the body’s immune system to act against cancer cells. These types of biological therapy, which are sometimes referred to collectively as 'immunotherapy' or 'biological response modifier therapy' do not target cancer cells directly. Other biological therapies, such as antibodies or segments of genetic material (RNA or DNA), do target cancer cells directly. Biological therapies that interfere with specific molecules involved in tumour growth and progression are also referred to as targeted therapies.
The NCI website has more information on Biologic/Immunotherapy
Biotherapies and Safe Handling
Biological therapies, such as monoclonal antibodies (MAB’s), immune checkpoint inhibitors (ICPI's) or tyrosine kinase inhibitors (TKI's), may be used to treat both malignant and non-malignant diseases within many specialties such as haematology, oncology, cardiology, rheumatology, immunology, gastroenterology and nephrology.
Historically, biological therapies have been treated as hazardous drugs which have specific preparation, administration, safe handling and waste management requirements. However, recent reviews have reclassified these drugs, removing them from hazardous drugs lists. This is because they do not fulfil the criteria for classification as a cytotoxic hazard anymore or there is insufficient information to make this classification.
Exceptions - biotherapies conjugated with cytotoxic drugs or radioactive isotopes. Conjugated biotherapies continue to be classified as hazardous.
What are the risks?
The risk to health care workers (HCW) can occur through four distinct mechanisms.
1. Dermal absorption
It is considered that the risk of dermal absorption is unlikely. However, for HCW who have skin abrasions/dermatitis this risk may increase.
2. Inhalation
Inhalation of aerosolised drug particles can pose a risk but this is more likely to occur during drug preparation as opposed to drug administration.
3. Oral absorption
Can occur with hand to mouth contamination. However, it is unlikely that the HCW will be exposed to levels high enough to cause problems.
Following the 5 Moments of hand Hygiene will minimise this risk.
4. Ocular absorption
There is a risk of the drug splashing the eyes causing ocular irritation but this is more likely to occur during drug preparation as opposed to drug administration.
Refer to the 
Australian Consensus Guidelines for Safe Handling of MAB's for more information
What consent is required prior to administration?
If being given for a non-malignant condition, then verbal consent only is required.
If being given for a malignant condition, then written consent is required. This is because it is usually part of a treatment plan that includes cytotoxic therapy.
Who can administer Biotherapies?
Any registered nurse who has completed the CDHB Level 1 IV therapy certification. For those health care workers employed outside the CDHB please refer to your local policy.
What Personal Protective Equipment (PPE) should I wear when handling, administering and disposing of the waste associated with Biotherapies?
| PPE | Yes | Consider |
| Standard gloves | | |
| Plastic apron | | |
| Mask | | Wear if concerned of risk of aerosolisation. Risk is greatest when dis/connecting lines particularly with new or inexperienced staff. |
| Goggles | | Wear if concerned of risk of ocular irritation. Risk is greatest when dis/connecting lines particularly with new or inexperienced staff. |
What else should I do?
When administering biotherapies intravenously, it is best practice to prime an infusion line with compatible intravenous fluid. Connect the infusion line to the patient (as per your local policy) then replace the priming solution with the drug. This will minimise exposure/drug loss during the line priming/connection process.
Using a dedicated trolley when connecting/disconnecting fluids from the infusion line and during the administration process can minimise environmental exposure.
Where do I dispose of the waste?
All waste from the administration process, including PPE, should be disposed of in a standard medical waste bin. There are no specific personal safe handling or waste management recommendations that patients should follow during and post administration.