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Clinical pharmacy and clinical trials (including case series)
Pharmaceutical research nurse: experience of the national tumour institute of milan
  1. G. Saibene,
  2. G. Antonacci,
  3. E. Togliardi,
  4. M. Mazzer,
  5. M. Iaquinto
  1. 1Fondazione IRCCS Istituto Nazionale Dei Tumori Farmacia Milano, Italy

Abstract

Background Often, due to a heavy workload, nurses are unable to analyse clinical protocols and administer experimental drugs without prior, detailed information regarding characteristics, dilution and side effects. Precise, reliable administration can only be guaranteed when resulting from complete familiarity with the clinical protocol. Sometimes, pharmaceutical handling is governed by mechanical, non-universal regulations encouraging administration errors. The clinical research activity taking place in the Pharmacy of the IRCCS Tumour Institute Foundation is complex due to the vast numbers of experimental protocols it handles. The pool of professionals comprises a research nurse who manages the practical, organisational aspects of the clinical trials conducted on patients.

Purpose To assess the nurse's knowledge regarding clinical studies through internal, investigatory procedures and instruments that monitor the quality of personnel training facilitating comprehension of the research protocols.

Materials and methods Literature research: study published in 1994 in Cancer Nursing of the EORTC Nursing Group lists the nurses involved in Clinical Trials, documenting participation and specific needs.

Internal research directed at hospital nurses who use experimental drugs more often.

Results Duration of the investigation was one month. 144 questionnaires were issued of which: 48% were completed and subsequently returned. Results show a disturbing lack of postbase training when one considers the role of the nurse and her influence on patient care and study results.

Conclusions It is imperative that nurses administering experimental drugs fully understand the therapeutic effects of such substances as well as administration guidelines in order to protect patient safety, hence guaranteeing optimum execution of the study. Appointing an experienced and reliable nurse for the pharmaceutical, clinical studies encourages colleague participation and guarantees quality control of performance. Such nurses constitute key figures for ensuring efficiency and correct conduct in clinical experimentation.

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