International guidelines for cytotoxic preparation in hospital pharmacy

J. Vandenbroucke UZ Gent, Belgique
Co-coordinateur « Standards of Practice » ISOPP

Many years ago, all kind of organisations started to write there own guidelines for safe handling of cytotoxic drugs in the hospital.
All these guidelines are written with the professional focus of the persons taken the initiative for it.

Hospital Pharmacists working in the production field, handle more practical issues of safe preparation. Hospital pharmacists working in the clinical oncology field have more interest in the immediate patient oriented aspects. Nursing is mainly focussed on safe administration en handling excreta.

Besides this, other aspects besides safe handling for the manipulators, are of major importance e.g. safety for the patient in relation with microbiological contamination, equipment and requirement for preparatory and administrative activities, education and training, …

ISOPP as the only world wide organisation of pharmacist working in all fields of oncology pharmacy took the initiative to gather as many as possible existing guidelines and to examine them on there strong and weak points. The ultimate goal for ISOPP is to provide an overall standard which contain a consensus on all possible aspects concerning safe handling, good clinical and manufacturing practice. It is the wish from the secretariat and the committee chairs to aim for a high level of standard, well known it is not obtained by everybody now a day, but a goal to which everybody can work on for the future.

The standard committee was inaugurated in 2003 and represent 14 countries from all over the globe with 22 individual members.
In July 2003 a database was installed and each member of the standard committee was able to fill in the guidelines he/she could have access to.

At least 18 standards were examined and at the end we came up with 29 topics to cover including personnel, education and training, facilities and equipment, cleaning, waste, spills, transport, homecare, clinical Pharmacy,…

Analysis were done by the February of 2004 and the writing could begin.

By June 2005 most of the topics with exception of some smaller topics, which probably will be included in existing ones were covered.

The first discussion with the whole standards committee started in September 2005 and by now the first 4 topics are in his final version.
By the end of 2005 the first draft of the total standard is to be hand over to the ISOPP secretariat for approval.

Launching the standard is foreseen for the ISOPP congress in Kula Lumpur / Malaysia taking place in April 4-6 2006.

During this Gerpac congress some of the most important aspects and discussions of the standard committee will be highlighted.

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