Exposure When Preparing Antineoplastic Drugs

How does chemotherapy drug exposure occur?

Because some of the antineoplastic drugs used in cancer treatment target cell division, they also pose a risk to the healthcare workers who prepare and administer them. Chemotherapy drug exposure often goes unnoticed: it has no smell and causes no immediate symptoms. That is why measures are taken from the outset at every step of the process, not "when something is felt".

The routes of exposure are:

Skin: The outer surface of vials, the preparation bench, connection points of the infusion set and surfaces touched with contaminated gloves.
Inhalation: Aerosol formed when a vial is opened or air is expelled from a syringe, and when powdered drugs are reconstituted.
Ingestion: Residue on the hands carried to the mouth by eating, drinking or touching the face.
Needlestick: Needlestick injury.

The risk chain is not made up only of pharmacists and nurses. The warehouse worker who receives drug boxes, the staff who clean the preparation area, the worker who collects the bedding of a patient receiving treatment and the person who carries the waste are also part of this chain.

Cytotoxic drug safety: the order of measures in the legislation

A significant proportion of antineoplastic drugs are carcinogenic or mutagenic substances; this property of a drug is stated in the manufacturer's safety data sheet or product information. For work with these drugs, the Regulation on Health and Safety Measures for Work with Carcinogens or Mutagens sets the following order:

Risk assessment (Art. 5): The type, level and duration of exposure are determined; all routes of entry, including the skin, are taken into account.
Reducing use (Art. 6): If technically possible, a less hazardous substance or process is used. Because one drug cannot be replaced by another in treatment, what changes here is usually the process.
Closed system (Art. 7): If substitution is not possible, closed systems are used as far as technically possible; if that is not possible either, exposure is reduced to the lowest level.
Organisation (Art. 7): The number of exposed employees is kept to a minimum, access to the area is controlled and the area is marked; eating, drinking and smoking are prohibited there.
Containers and waste (Art. 7): Drugs and their waste are kept in clearly labelled, leak-proof closed containers.
Emergencies (Art. 7): Situations that could lead to high exposure, such as spills, are addressed in the emergency plan.
Records (Art. 14): The employer keeps an up-to-date list of employees in risky work and exposure records.

The Regulation on Health and Safety Measures for Work with Chemical Substances also applies to these substances, without prejudice to the provisions of the carcinogens regulation. For the general framework, see our article on the chemical substances regulation.

Preparation: biosafety cabinets and closed systems

Preparation is the stage with the most intense exposure. The elements of a good preparation arrangement are:

Controlled area: Preparation is carried out only in a separate, marked area entered only by authorised persons.
Biosafety cabinet or isolator: A class II biosafety cabinet suitable for cytotoxic drug preparation or a closed isolator is used. The cabinet's performance tests, filter changes and maintenance are carried out at the intervals set by the manufacturer and the relevant standard, and recorded.
Closed transfer: Closed system transfer devices, which prevent the drug from escaping into the room between vial and syringe, are the practical equivalent of the "closed system" principle in the Regulation.
Technique: Locking (Luer-lock) connections are used, and excessive pressure is not built up in the vial. The outer surface of the prepared product is wiped before it leaves the cabinet and the product is placed in a leak-proof bag.
Working practice: Only one person works in the cabinet at a time; the cabinet is not filled with materials, and the air curtain is not disrupted by sudden arm movements.

The receiving stage is also important: drug boxes are opened with gloves in the warehouse, and damaged packaging is treated as a spill.

Oncology nurse risks: administration and patient care

Oncology nurse risks intensify when the drug leaves the preparation room and reaches the patient:

Where possible, the infusion set is primed at the preparation stage and with a drug-free fluid.
An absorbent pad is placed under the connection point when the set is connected and disconnected.
Gloves tested for resistance to the drugs and a fluid-resistant gown are used throughout administration.
The urine, faeces and vomit of a patient receiving treatment may also carry drug residues. Employees who come into contact with these excreta use gloves and a gown; soiled bedding is collected in a separate bag.

Chemotherapy PPE: selection by task

Task	Gloves	Gown	Eyes and face	Respiratory
Receiving and storage	Single pair, resistance tested	Needed for damaged boxes	Needed for damaged boxes	Usually not needed
Preparation in the cabinet	Double pair, resistance tested	Fluid-resistant, back-closing, with cuffs	The cabinet glass provides protection	Not needed if the cabinet works correctly
Administration	Resistance tested	Fluid-resistant	Goggles or visor if there is a splash risk	Usually not needed
Patient excreta and bedding	Gloves	Gown	Visor if there is a splash risk	Not needed
Spill response	Double pair	Fluid-resistant	Goggles and face visor	Respiratory protection with a suitable particle filter

PPE is selected according to the risk assessment in accordance with the Regulation on the Use of Personal Protective Equipment at Workplaces. The glove change interval is set according to the manufacturer's resistance data; gloves are changed immediately when punctured or contaminated. For general selection principles, see our article on choosing work gloves.

The chemotherapy spill kit and waste management

A spill is an event that can lead to high exposure in a short time. A chemotherapy spill kit is kept ready in the preparation area, on the trolley used to transport drugs and in the department where administration takes place. The kit typically contains double gloves, a fluid-resistant gown, overshoes, goggles, a face visor, respiratory protection, absorbent pads, a scoop for broken glass, leak-proof waste bags, a warning sign and an incident form.

Response steps:

Close off the area, move people away and put up the warning sign.
Put on the PPE in the kit.
Collect the liquid with absorbent pads, working from the outside inwards; for a powder spill, cover it with a damp pad so as not to make the powder airborne.
Pick up broken glass with the scoop, not by hand.
Clean the area several times according to the institution's written cleaning procedure.
Put all materials in the cytotoxic waste container and record the incident.

Art. 4 of the Regulation on the Control of Medical Waste defines waste containing cytotoxic (antineoplastic) products used in cancer treatment and the body excreta, such as urine and faeces, of patients treated with these drugs as genotoxic waste. This waste may not be put through sterilisation (Art. 17), and medical waste is not mixed with hazardous waste (Art. 10). Cytotoxic waste is therefore collected in separate, labelled containers. For employee safety in the medical waste stream, see our article on medical waste and employee safety.

Health surveillance and pregnant employees

Employees exposed to carcinogens or mutagens are placed under health surveillance before exposure and at regular intervals afterwards (Art. 16). Under Annex 3 of the Regulation, surveillance covers recording the occupational and medical history, examinations and, where possible, biological monitoring. The list of exposed persons and health surveillance records are kept for at least 40 years after exposure ends (Art. 17).

For pregnant or breastfeeding employees, Art. 6 of the relevant regulation requires the employer to assess the effect of hazardous agents on these employees. Under Art. 7, if there is a risk, working conditions or hours are changed temporarily; if this is not possible, the employee is moved to other work. The assessment begins when the pregnancy is reported to the employer. For details, see our article on pregnant and breastfeeding employees.

Our article on sharps injuries explains what to do after a needlestick, and our healthcare facilities sector page gives the general framework for healthcare facilities. We provide risk assessment and workplace physician services together at healthcare facilities in Bursa and the surrounding provinces; we observe preparation and administration processes on site and keep the list of exposed employees up to date.

Frequently Asked Questions

Can chemotherapy drugs be prepared without a biosafety cabinet?

The Regulation on Carcinogens or Mutagens requires closed systems and engineering measures where substitution is not possible. Preparing cytotoxic drugs on an open bench does not follow this order of measures; preparation must be carried out in a suitable cabinet or isolator.

How often is an employee who prepares chemotherapy drugs examined?

The workplace physician sets the frequency according to exposure and the workplace's hazard class. Surveillance begins before exposure and continues at regular intervals; records are kept for at least 40 years after exposure ends.

Where should the spill kit be kept?

At every point where the drug is present: in the preparation area, on the transport trolley and in the department where administration takes place. Everyone should know where the kit is, its contents should be checked regularly and employees should receive practical training in its use.

Can cytotoxic waste be put in the medical waste bag?

No. The Regulation on the Control of Medical Waste defines this waste separately as genotoxic waste and does not allow it to be sterilised. It is collected separately from infectious medical waste, in labelled, leak-proof containers.