Cytotoxic Drugs and their Safety Considerations

Safety Considerations

Given the increase in the variety and use of cytotoxic drugs, and also the number of facilities handling them, it is timely to remind and/or update people who come into contact with them on safety considerations, as cytotoxics can be carcinogenic, mutagenic and teratogenic. Some potential adverse effects include foetal loss and malformations, abnormal blood cell count, liver damage, abdominal pain, hair loss, nasal sores, and vomiting.

Similarly, the uptake in use of monoclonal antibodies (MABs) is presently causing some concern over their safety profiles due to their complex and incompletely understood action at a molecular level, and the number of women of childbearing age experiencing chronic low level exposure, such as nursing staff together with other medical professionals. As different MABs have different effects on different human cells, caution should be taken when coming into contact with these agents according to their potential hazards.

Many drugs when used in cancer treatment may be classified as non-toxic, such as the non-cytotoxic antineoplastics everolimus, imatinib, and sunitinib; and the hormonal antineoplastics such as cyproterone and letrozole. These are classified as Pregnancy Category D and, as such, care should be taken when handling these medications especially by women of childbearing age or who may be pregnant. Staff should be encouraged to refer to the manufacturer’s product information before exposure.

Exposure can occur during: preparation, administration, transportation, storage, handling, waste disposal, and when cleaning up spills; and can involve contact with skin, eye or mucous membranes, inhalation of aerosols or powders, and sharps injuries.

For each of these means of exposure there should be a protocol available detailing what precautions are necessary. All staff who handle cytotoxics must receive training and education appropriate to their level of involvement in these processes. When a high standard of risk control is in place, and adhered to, threats to health are greatly reduced.

All staff handling cytotoxic drugs should be provided with written information on the potential risks of handling these medications and suitable precautions; this advice should also be shared with volunteers and contractors who are not staff. Employers should ensure that only employees who have received and attained the appropriate level of training handle cytotoxic drugs and related waste.

Any health services (including hospitals and medical centres) that are unable to provide the facilities, equipment, and training necessary to provide a cytotoxic drug preparation service should outsource this responsibility to an approved provider, such as HPS Pharmacies.

A minimum set of operating procedures should include:

• Preparation of parenteral treatments,
• Preparation of topical treatments,
• Preparation of oral treatments,
• Operation and maintenance of cleanrooms and ante-rooms used in the production of cytotoxic drugs,
• Operation and maintenance of cytotoxic safety drug cabinets or pharmaceutical isolators used for the production of cytotoxic drugs,
• Receipt and storage of cytotoxic drugs,
• Selection and use of personal protective equipment,
• Cytotoxic waste management,
• Transport of cytotoxic drugs,
• Management of cytotoxic spills, and
• Staff management.

All of these procedures are addressed by HPS Pharmacies when handling cytotoxic drugs and the final product is supplied ready for administration at the health service thereby removing multiple risks of exposure.

Safe Work Practices

Handling techniques can involve the use of both parenteral and non-parenteral preparations and should address:

Preparation

Cytotoxic safety drug cabinets must be used. For parenteral use, glass vials should be avoided if possible due to; their increased risk of breakage and spillage, the care needed to contain excess drug solution and air when priming, and to avoid generation of pressure differentials that might lead to airborne contamination. Only one drug should be in the cabinet at any one time.

Non-parenteral preparation should also involve the use of a safety cabinet especially when making mixtures or ophthalmic products. Preparation of creams should preferably be avoided due to high risks of contamination.

Again, most health facilities are unable to provide the level of expertise necessary and HPS Pharmacies (as a recognised provider) is able to supply ready prepared medications for immediate use.

Administration

Exposure while administering drugs can occur through handling, spills, splashing, inhalation, and sharps injuries. Risks can be reduced by using closed administration devices, Y infusion lines or Y site adaptors, needleless administration systems, personal protective equipment, as well as having access to a spill kit.

When administering oral tablets and capsules, they must be handled in a manner which; minimises or avoids skin contact, liberation of powdered drug into the air or onto counting trays and other surfaces, and in a manner which avoids chemical cross-contamination. Gloves should be used, equipment cleaned after use, and be purpose dedicated. Tablets should not be crushed or broken.

Cytotoxic Waste

Cytotoxic waste includes any residual material following a patient’s treatment; and the materials or equipment associated with the preparation, transport, or administration of the drug therapy. It can include contaminated waste from preparation, IV sets and containers, linen, dressings and bandages, contaminated personal protective equipment, and dose administration aids.

Cytotoxic waste must be disposed of safely to reduce the risk of exposure to waste management workers and contamination of landfill sites. A cytotoxic waste bin should be provided; other contaminated products in addition to those listed above may include nappies, ostomy bags, catheters and the like.

Spills

Spills can involve cytotoxic drugs in all forms; liquid, powder, tablets (whole or broken), or creams. A risk assessment should be performed to identify all areas where there is a likelihood of a cytotoxic spill. Contamination may involve floors, work surfaces, equipment, bedding, clothing, and the patient or their carer/staff member.

A cytotoxic drug spill kit must be available in areas where cytotoxic drugs are used; wherever they are handled, stored, transported, or disposed of. People in the vicinity of a spill should be warned to stay clear and the area isolated. Ancillary workers should only assist in the containment of a spill, until trained personnel are available, by preventing access to the contaminated area if safe to do so.

An emergency shower should also be available in the vicinity where cytotoxics are handled or administered in order to rinse major spills on patients and/or employees to decrease potential harm.

Spill management strategies should be developed by all employers and involve the use of a cytotoxic spills register.

In conclusion, it can be seen that cytotoxic drugs require a great deal of attention to safety during production, preparation, handling and disposal. Using an approved provider such as HPS Pharmacies can greatly reduce exposure risk, as the cytotoxics are supplied already prepared thus removing staff involvement in production, preparation, and some handling procedures.

All staff involved in the supply of cytotoxic drugs from the doctor down to any ancillary workers should be provided with training relevant to their level of exposure, and protocols put in place to ensure that their safety is paramount.

If cytotoxics are treated with respect, ordered from approved providers, and administered correctly, there is little likelihood of any unwanted exposure, and staff can feel entirely confident about their involvement in patient care when using these drugs.