Suitable Protective Clothing when Handling Cytostatics Drugs
What are cytostatics?
Cytostatics have been an essential class of drugs for treating cancer for many years. Many hospitals, pharmacies, doctor's practices and outpatient facilities handle cytostatic drugs.
Activities involving cytostatics will further increase in the future and veterinary medicine will also use this class of drugs.
Risks for humans and the environment
Cytostatics are highly potent medicines and thus constitute a potential danger for all persons working with them. Many cytostatic drugs have mutagenic or carcinogenic effects, impair fertility or damage foetuses.
The immediate impact in case of contact with the skin or mucous membrane may be irritating, caustic and sensitising. In therapeutic doses, cytostatic drugs particularly damage cells with a high cell division rate, such as those in the bone marrow, the intestinal mucosa, hair follicle cells and in gonads, as well as the body's own immune system. Generally, cytostatics are not biodegradable and thus pose a risk to the environment.
Risk assessment
As a matter of principle, the employer has to evaluate the working conditions and risks when handling cytostatic drugs before the work begins and at regular intervals. If necessary, measures for improving the conditions must be taken. Explanations as to the subsequent risk assessment can be found in particular in the Technical Regulation TRGS 400 "Risk assessment for working with hazardous substances" as well as TRGS 401 (Risk due to skin contact) and TRGS 402 (Risk due to inhalation).
Expectant and nursing mothers must not be exposed to cytostatics; teenagers may only handle them, if this is
necessary for achieving their training objectives and they are being supervised by a specialist for their own protection.
Personal protective equipment
The TRGS 525 stipulates what personal protective equipment is required. The regulation distinguishes between requirements for the preparation of cytostatics, cleaning in the safety cabinet and in the case of accidental spillage.
A) For preparing cytostatics
When preparing cytostatic drugs in a safety cabinet, the following protective equipment must be worn and, in case of contamination or damage, changed immediately:
1. Protective gloves (e.g. tight, non-slip gloves made from nitrile would be suitable)
2. High-necked gown with long sleeves and tight sleeve cuffs
B) For cleaning
In case cleaning in the safety cabinet involves more than merely wiping the worktop, the following personal protective equipment must be worn:
Protective gown, impermeable to fluids, with long sleeves and tight cuffs
1. Protective goggles with side protection
3. Protective gloves
4. Respiratory protection mask, corresponding at least to protection level FFP2 in accordance with the regulations by the Employer's Liability Insurance Association for the use of respiratory protection equipment (BGR 190).
C) In case of accidental spillage
When preparing or administering cytostatics, at least the following equipment must be kept at hand in order to remove accidental contamination:
1. Overshoes, protective gown that is impermeable to fluids with long sleeves and tight cuffs, protective goggles and protective gloves
2. Respiratory protection mask, corresponding at least to protection level FFP2 in accordance with the Employer's Liability Insurance Association's "Regulations for the use of respiratory protection equipment (BGR 190)"
3. Cut tissues in sufficient quantity
4. Waste bin and hand shovel
Requirements and things to consider when using gloves
It is best to use disposable gloves with long gauntlets and possibly rolled cuffs, which ensure secure closure above the sleeve cuffs. Tight, non-slip gloves, e.g. made from latex or nitrile, would be suitable.
From an occupational health and safety perspective, the gloves must meet the quality requirements of the European standard DIN EN 374 .
The material of the gloves should be coloured, so that flaws, holes and tears can quickly and safely be detected. In practice, the double-gloving technique, i.e. wearing two pairs of gloves of different materials (e.g. latex and nitrile), has proven very effective for eliminating the remaining risk.
The length should be chosen so that the gloves cover the sleeve cuffs of the protective gown.
Studies for determining permeability have shown that gloves made from latex, nitrile rubber or neoprene are most likely to be sufficiently thick for handling cytostatic drugs.
Gloves must be changed immediately, if they have been damaged in such a way that fluid can come into direct contact with the skin. Regardless of visible contamination or damage, the gloves should be changed at least every 30 minutes, in order to prevent ingestion of non-visible contamination or damage.
In order to prevent contamination of the unprotected hands, the gloves should always be turned inside out when taking them off.
