title: A centralized Pharmacy Unit for cytotoxic drugs in accordance with Italian legislation.
abstract: BACKGROUND
  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.
authors: Pharmacy Unit, Centro di Riferimento Oncologico, Aviano, Italy. pbaldo@cro.it
authors: Paolo
authors: P
authors: Baldo
authors: Antonella
authors: A
authors: Bertola
authors: Giancarlo
authors: G
authors: Basaglia
authors: Mariarosa
authors: M
authors: Moneghini
authors: Roberto
authors: R
authors: Sorio
authors: Enrico
authors: E
authors: Zibardi
authors: Renzo
authors: R
authors: Lazzarini
authors: Paolo
authors: P
authors: De Paoli
mesh_terms: D003603:Cytotoxins; D004339:Drug Compounding / Q000592:standards*; D019983:Guideline Adherence; D006801:Humans; D007558:Italy; D010607:Pharmacy Service, Hospital / Q000331:legislation & jurisprudence* / Q000458:organization & administration
chemical_list: D003603:Cytotoxins