title: Safety and quality assurance of chemotherapeutic preparations in a hospital production unit: acceptance sampling plan and economic impact.
abstract: OBJECTIVE
  The opportunity to apply a sampling plan was evaluated. Costs were computed by a microcosting study.
  
  
  METHODS
  In 2003, a sampling plan was defined to reduce the number of chemotherapy quality controls while preserving the same level of quality. Recent qualitative and quantitative changes led us to define a second sampling plan supplemented by an economic evaluation to determine the cost and cost-savings of quality control.
  
  
  METHODS
  The study considers preparation produced during four semesters classified into three groups. The first one includes drugs produced below 200 batches a semester. Group 2, those for which the lot of preparation lots would have been rejected twice among these four semesters. Group 3, those would have been accepted (≥3 'acceptable lot'). A single sampling plan by attributes was applied to this group with an acceptance quality level of 1.65% and a lot tolerance percent defective below 5%. A micro-costing study was conducted on quality control, from the sampling to the validation of the results.
  
  
  RESULTS
  Among 39 cytotoxic drugs, 11 were sampled which enabled to avoid a mean of 17,512 control assays per year. Each batch of the 28 non-sampled drugs was however analyzed. Costs were estimated at 2.98€ and 5.25€ for control assays depending of the analytical method. The savings from the application of the sampling plans was 153,207€ in 6 years.
  
  
  CONCLUSIONS
  The sampling plan allowed maintaining constancy in number of controls and the level of quality with significant costsavings, despite a substantial increase in drugs to assay and in the number of preparations produced.
authors.affiliation: Pharmacology and Drug Analysis Department and Department of Clinical Pharmacy, Institute Gustave Roussy, Villejuif, France.
authors.forename: A
authors.initials: A
authors.lastname: Paci
authors.forename: I
authors.initials: I
authors.lastname: Borget
authors.forename: L
authors.initials: L
authors.lastname: Mercier
authors.forename: Y
authors.initials: Y
authors.lastname: Azar
authors.forename: R P
authors.initials: RP
authors.lastname: Desmaris
authors.forename: P
authors.initials: P
authors.lastname: Bourget
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000191:economics* / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000191:economics; D010607:Pharmacy Service, Hospital / Q000191:economics* / Q000379:methods / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000191:economics* / Q000379:methods / Q000592:standards*; D012494:Sampling Studies
chemical_list: D000970:Antineoplastic Agents