The preparation process for cytotoxic drugs is connected with a high level of hazards to the operator preparing the product and can affect the operator's health in many aspects.
To protect the health of the personnel is one of the major challenges in cytotoxic production. Any personal protective equipment needs to be in line with the European PPE guideline 89/686/EWG. The individual choice of the product is then also depending on an individual risk analysis on site.
At the same time, any measure needs to be taken in order to ensure the integrity of the end product. In order to ensure both the protection of the operator and the end product, the correct selection and use of personal protective equipment (PPE) is an indispensable prerequisite. PPE must be worn during any activity such as handling vials or finished product, drug packaging and labeling or disposing of waste.
The required PPE includes:
- gowns or overalls
- head, face and eye protection
- overshoes and boots
In specific cases sleeves and aprons need to be worn in addition.
Overalls should be PPE Cat. III, Type 4, 5, 6. If no PPE certification is recommended, additional measures need to be taken such as wearing sleeves and aprons, in order to avoid any hazard to the operator.
In order to prevent any facial or respiratory injuries, appropriate face masks, respiratory masks - during disinfection activities - and eye protection need to be applied. Face, respiratory and eye injuries are upmost serious, because most of the time irreparable. Appropriate protection with face and respiratory masks and goggles need to be applied to ensure integrity. A certification according to European Standard EN 166 is mandatory for safety.
When choosing the right glove for this application, several factors need to be taken into consideration. Foremost these are the protection against specific drugs being used as well as against other hazards or chemicals in the work place. Protection of the products from external contamination as well as comfort, fit, ergonomics and cost also need to be part of the equation.
Gloves specifically need to be tested along EN 374:2003 on permeation and penetration (“break-through” time). Additional security is provided if gloves are also tested against ASTM F 6978. In order to offer the operator an additional layer of protection during the preparation of cytotoxic drugs, the common practice of wearing 2 pairs of single use gloves (double donning) is highly recommended.
Information on European regulations and standards of practice for personal protection can be found in the "PIC/S Guide to Good Practices for Preparation of Medicinal Products in Pharmacies", in the EU GMP Guidelines, Annex 1, in QuapoS 5 and in the ISOPP. Local regulations may apply and need to be considered in addition.