A centralized Pharmacy Unit for cytotoxic drugs in accordance with Italian legislation

Paolo Baldo, Antonella Bertola, Giancarlo Basaglia, Mariarosa Moneghini, Roberto Sorio, Enrico Zibardi, Renzo Lazzarini, Paolo De Paoli

Research output: Contribution to journalArticlepeer-review


Rationale: In May 2002, a centralized Unit for cytotoxic drug preparations [Unità Farmaci Antiblastici (UFA)] was established at the Centro di Riferimento Oncologico, Aviano, Italy. The Unit was created following provisions under Law 626/94 (Legislative Decree - Ministry of Health), governing the safe handling of cytotoxic drugs. New guidelines governing drug preparation ('NBP' standards of preparation) published in Italian Pharmacopoeia (2002, XI Edition) have been mandatory since 2004 and set out rules for proper pharmacy practice applicable also to antineoplastic drug preparations. Aims and objectives: To review legislation on cytotoxic drug preparation and compliance within our Unit, to assess current quality levels and identify those areas requiring improvement. Methods: The study reviewed: (1) the organization and equipment of the Unit UFA and its working methodology; (2) written documentation concerning work procedures; (3) the stability and sterility of injectable drug formulations; (4) staff training, occupational exposure and risk management; (5) accidents and mistakes occurring in the UFA service. Results: The study showed up the strengths of our Unit and identified those areas which need improvement to guarantee product quality excellence. Conclusions: A critical evaluation of the whole cytotoxic preparation process is a useful method for quality improvements to be initiated. Knowledge regarding risks, techniques, and procedures for handling antineoplastic drugs is growing. Ongoing analysis will ensure greater patient and health care worker safety.

Original languageEnglish
Pages (from-to)265-271
Number of pages7
JournalJournal of Evaluation in Clinical Practice
Issue number2
Publication statusPublished - Apr 2007


  • Antineoplastic drug
  • Cytotoxic drug
  • Legislation
  • Pharmacy service

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Health Information Management
  • Nursing(all)


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