Safety and quality assurance of chemotherapeutic preparations in a hospital production unit: acceptance sampling plan and economic impact.
J Oncol Pharm Pract
; 18(2): 163-70, 2012 Jun.
Article
em En
| MEDLINE
| ID: mdl-21558471
ABSTRACT
OBJECTIVE:
The opportunity to apply a sampling plan was evaluated. Costs were computed by a microcosting study.SETTING:
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.CONCLUSION:
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Serviço de Farmácia Hospitalar
/
Garantia da Qualidade dos Cuidados de Saúde
/
Antineoplásicos
Tipo de estudo:
Health_economic_evaluation
/
Qualitative_research
Idioma:
En
Revista:
J Oncol Pharm Pract
Assunto da revista:
FARMACIA
Ano de publicação:
2012
Tipo de documento:
Article
País de afiliação:
França