Application of an acceptance sampling plan for post-production quality control of chemotherapeutic batches in an hospital pharmacy.
BACKGROUND
About 26,000 chemotherapeutic batches were produced in 2003 in the Institute Gustave Roussy and 83% were qualitatively and quantitatively assessed in post-production controls via an analytical platform. The rate of non-conformity (outside the specification limits of the target concentration +/-10%) decreased from 8.9% to 2.2% between years 2001 and 2003. A cost- and time-saving acceptance sampling plan was applied to assay fewer batches whilst maintaining an accurate estimate of the quality level.


METHODS
The opportunity to apply a single sampling plan by attributes with an acceptance quality level of 2.2% was evaluated. A prognostic study using a logistic regression model was performed for some drugs to identify risk factors associated with the non-conformity rate of preparations.


RESULTS
Out of 26 drugs, 17 have not been sampled, since they were prepared less than 400 times per year. For six drugs, a reduction of about 50% in the number of assays was estimated. Three drugs were "at risk" of being non-conform: for these drugs, all batches were analysed.


CONCLUSIONS
The sampling plan allowed a reduction of almost 8000 analyses with respect to the number of batches analysed for 6 drugs. For the 3 drugs with the higher risk to be non-conform, associated risk factors were identified to set up corrective actions.
Borget
Isabelle
I
Department of Clinical Pharmacy, Institut Gustave Roussy, Villejuif, France.
Laville
Isabelle
I
Paci
Angelo
A
Michiels
Stefan
S
Mercier
Lionel
L
Desmaris
Romain-Pacôme
RP
Bourget
Philippe
P
D000970:Antineoplastic Agents / Q000494:pharmacology*; D002626:Chemistry, Pharmaceutical / Q000295:instrumentation / Q000592:standards; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004339:Drug Compounding / Q000295:instrumentation / Q000592:standards*; D004355:Drug Stability; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000592:standards*; D010607:Pharmacy Service, Hospital / Q000191:economics* / Q000706:statistics & numerical data; D011786:Quality Control; D012372:ROC Curve; D012307:Risk Factors
D000970:Antineoplastic Agents; D004364:Pharmaceutical Preparations