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Published on 23 March 2010

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Cytotoxic handling – where are we today?

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The safe handling of cytotoxic drugs is important when establishing both a safe and sterile product for patients and a safe preparation environment for the staff preparing the cytotoxics

Dr Tilman
Schöning
Head of the Oncology-
Pharmacy-Unit
Pharmacy Department
University Hospital of
Heidelberg

Dr Torsten
Hoppe-Tichy
Chief Pharmacist
Pharmacy Department
University Hospital of
Heidelberg

The development of safe handling of cytotoxic drugs began about 25 years ago and continues to be based on a programme of enduring improvement. It is important to establish both a safe and sterile product for patients and a safe preparation environment for those employees responsible for reconstituting cytotoxics.

Present standards rely on preparation in a separate and safe area, usually inside a pharmacy, on a sterile workbench or in an isolator. Isolator hoods feature a HEPA filter and laminar air flow, which help to minimise the release of cytotoxic aerosols.

However, there are other considerations. Risk assessments need to be carried out and staff should be well educated and well trained. The training of new employees must be thorough and regular instructions should be issued related to the specific workplace, such as preparation or transport.

Personal protective equipment includes protective water-resistant gowns and gloves and, in special cases, respiratory protective masks and protective eyewear.

Double gloving with drugs that provide feasible penetration test results should be standard. Gloves should be changed within  standardised time periods. An acceptable work safety regime should be introduced based on the use of absorbent and impermeable workmats, compresses and swabs, single-use syringes, waste containers, transfer needles, mixing adaptors and, especially, pressure-release systems with hydrophobic air filters (“spikes”). This regime should be supported by adequate, suitable preparation techniques.

There has been some remarkable progress in this area. This includes needleless luer-lock connections on infusion containers, needleless connection of infusion sets and the use of “closed systems” for the complete preparation process and administration. Nevertheless these options may only be an addition to an adequate safety management system described above.

Other measures include regular, standardised cleaning of working areas with an appropriate detergent, defined procedures in case of the release of cytotoxics and the monitoring of contamination using the swab method. If necessary the results of monitoring should then be used to re-evaluate working processes.

Implementing these measures is good working practice but there will still be challenges in providing the best safety procedures when handling cytotoxics.



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