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Expert panel report


Safe preparation and administration of cytotoxics


A European Pharmacy Expert Panel concluded that new products and new working methods are needed to ensure safe handling of cytotoxic drugs


Christine Clark BSc, MSc, PhD, FRPharmS, FCCP(Hon) Editor, HPE


Hospital Pharmacy Europe recently hosted a meeting of a panel of European expert pharmacists in Frankfurt, Germany to review the safe preparation and administration of cytotoxic drugs. Topics included hazards of cytotoxic drug preparation, safety assurance requirements and the likely impact of the European Resolution CM/ResAP(2011)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients. Participants also had the opportunity to examine a number of devices.


In order to set the scene, each participant gave a short presentation on the preparation of cytotoxic drugs in their hospitals. Centralised pharmacy cytotoxic preparation services were operated by all hospitals represented. All countries supported the principle of providing as many injections as possible in ready-to- use (RTU) or ready-to-administer (RTA) form, although in practice this is sometimes difficult to achieve. One aim of the Spanish hospital pharmacy society’s ‘2020 initiative’ is for 100% of hospitals to be dispensing intravenous doses in a RTU or RTA form by 2020. The presentations showed that European countries have much in common but there are local variations.


Occupational exposure Occupational exposure of healthcare workers to cytotoxic drugs was an issue that concerned all pharmacists. The need


Bertrand Favier


to protect pharmacy personnel, ward staff and others who might come into contact with cytotoxic drugs was recognised by all participants.


In order to minimise contamination of the working area and reduce the likelihood of occupational exposure of pharmacy personnel, pharmacy technicians prepare cytotoxic doses in vertical laminar flow cabinets or isolators. They often use reconstitution spikes rather than needles to minimise leakage of droplets or aerosols of the drug solutions. Other important measures include frequent changes of the work surface protective cover, regular changes of gloves and the use of validated cleaning processes. All these measures are required to minimise contamination of the working area with cytotoxic drugs. Dermal exposure is an important route of contamination for personnel involved in preparation of cytotoxic doses and ‘double-gloving’ is important to minimise


Ana Herranz


the chances of skin coming into contact with contaminated surfaces. Some researchers have investigated the extent of contamination with cytotoxic drugs in the preparation areas of pharmacies, using highly sensitive techniques that can detect picogram quantities of cytotoxic drugs. Measurements made in Danish hospital pharmacies have shown that environmental contamination with cyclophosphamide and ifosfamide has fallen to very low levels over a seven-year period. It is of interest that this has been achieved without the use of closed system transfer devices (CSTDs). Training of operators in good cytotoxic drug handling technique and correct use of all devices is probably the most important factor in minimising local contamination.


Closed systems


Closed system transfer devices are advocated to minimise leakage of


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