Chemical contamination during the preparation of cytotoxics: validation protocol for operators in hospital pharmacies.
OBJECTIVE
The chemical contamination during the preparation of cytotoxics remains a serious problem in hospital pharmacies and the operators could contribute to this risk during their manipulations. A validation protocol was developed using a non-toxic, highly detectable tracer, quinine dihydrochloride.


METHODS
Further, a method for a high recovery extraction and quantification of this marker, and a protocol covering the critical operations of cytotoxic preparation, was developed and validated. Various devices were used to fill the syringes and perfusion bags. All the filled containers and used materials were collected at the end of the protocol and the tracer was extracted in water. The contaminated water was analyzed by fluorimetry. The number of spots on the working pads was counted under ultraviolet light. During a total of 28 sessions, the procedure was applied by 20 different operators.


RESULTS
The mean cumulated quantities of contamination were 6.2 µL (0.6-23.8) and >10 spots (0-20), which was considered as high. No correlation was observed between the contamination rate and the operator's experience.


CONCLUSIONS
This validation protocol facilitates controlling the operators' working 'cleanliness' and helps to improve the initial and continuing training. This simple test presents an effective answer for the important issue of the chemical safety of operators.
Pharmacy, Hospitals of University of Geneva, Switzerland. farshid.sadeghipour@hcuge.ch
F
F
Sadeghipour
K Ing
KI
Lorenzini
C
C
Ziewitz
M
M
Dobrinas
M
M
Fleury
P
P
Bonnabry
D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000737:chemistry*; D004209:Disposable Equipment; D004339:Drug Compounding / Q000295:instrumentation / Q000379:methods*; D004340:Drug Contamination / Q000517:prevention & control; D004866:Equipment Contamination / Q000517:prevention & control; D005456:Fluorescent Dyes / Q000032:analysis; D006801:Humans; D007263:Infusions, Parenteral; D007318:Inservice Training / Q000379:methods; D057230:Limit of Detection; D010564:Personnel, Hospital / Q000193:education; D010607:Pharmacy Service, Hospital; D011361:Professional Competence; D011482:Protective Devices; D011785:Quality Assurance, Health Care / Q000379:methods; D058996:Quality Improvement; D011803:Quinine / Q000032:analysis; D015203:Reproducibility of Results; D012492:Salts / Q000032:analysis; D014466:Ultraviolet Rays; D000078329:Workforce
D000970:Antineoplastic Agents; D005456:Fluorescent Dyes; D012492:Salts; D011803:Quinine