[Consideration on Expiration Days Setting for the Introduction of Drug Vial Optimization].

When drug vial optimization(DVO)is implemented, the medical facilities will be forced to bear the cost of the divided- use drugs not used up within the expiration date. We determined the expiration days to use up the residual drugs in the vial within the expiration period. The cost of discarded drugs was calculated from the prescription data of anticancer drugs. We estimated the discarded drug volumes when the expiration period was 0, 1, 2, 7, 8, 14, or 28 days for each liquid anticancer drug. When the expiration period was 7 days, the discarded amount was equivalent to 5.5% of the amount on 0-day expiration period. Only one drug with a 28 day expiration period had to be discarded. When the expiration period is 1 to 2 days, drugs are always discarded and the medical facilities must bear the cost of the wasted drugs. If the expiration period is 7 days or more, most of the medicine will not be discarded. To introduce DVO to medical facilities without economic loss, extending the expiration period of DVO must be considered.

Verification of surface contamination of Japanese cyclophosphamide vials and an example of exposure by handling.

PURPOSE: Cyclophosphamide (CP) contamination has been detected in Japanese hospitals. In other countries, the surface contamination of CP vials has been reported; however, the manufacturing process of Japanese CP vials is unknown, so the conditions are not necessarily the same as in other countries. This study aimed to establish whether vial surface contamination also occurs in Japan. METHOD: Contamination of vial surfaces was examined with a wipe test. Urine samples were taken from a pharmacist, engaged solely in dispensing work, for 29 h. It was also investigated whether CP vials were dispensed during the urine sampling period. In addition, vial surfaces, purposely coated with CP and then washed, were examined using wipe tests. RESULT: CP was detected at 30-60% in vials, which was 11-62 ng (0.10-0.54 ng/cm(2)). One of the urine samples was contaminated (CP 13.5 ng); this was taken on Day 2 (11:35 AM). CP was not detected among the washed vials. DISCUSSION: This study shows that the surface of Japanese CP vials was contaminated and that it was probable that healthcare workers were exposed to CP. CP absorption by the pharmacist was probably due to dermal uptake while dispensing. Washing the vial is considered effective to avoid CP exposure. Manufacturers should be more proactive to prevent contamination and healthcare workers should comply with exposure prevention rules. Cytotoxic drugs should be included in institution monitoring lists.

Investigation on residual-related error and the effect of solution properties using protective devices for the reconstitution of cytotoxic agents in actual situations.

PURPOSE: Three products can be used in Japan for the reconstitution of cytotoxic agents: PhaSeal, Chemo CLAVE and Chemo Mini Spike (CMS). The low preparation volume may be affected by residual-related volume in their devices. In this study, the residual-related error in their devices was examined and compared. METHOD: The blank of each component of these devices was weighed using a precision electric balance. After ejecting distilled water (DW) for injection, each was weighed again with the balance. In addition, for etoposide in the cases of PhaSeal and Chemo CLAVE, the components of the devices were similarly weighed. RESULT: The weight gains of each device after ejecting DW were as follows: CMS-V (440 mg) greater than the combined components of Chemo CLAVE (128-171 mg)/CMS-MT (123 mg) greater than the combined components of PhaSeal (13-56 mg). For etoposide, the weight gains of PhaSeal (208 mg) and Chemo CLAVE (223 mg) showed no significant difference. The priming volume of each device was calculated from the specific gravity of water. The residual-related volume was 'CMS-V > Chemo CLAVE, CMS-MT > PhaSeal', although this was very slight in actual situations. CONCLUSION: The residual-related volume was marked in its low preparation volume. In water-soluble drugs, the residual volume of PhaSeal was lowest of the devices in this study, but in viscous drugs, such as etoposide, the residual volume of PhaSeal was almost identical to Chemo CLAVE; that is, the residual volume of these devices was affected by the solution property. The residual-related volume in the devices will lead to errors; therefore, residual-related errors need to be considered in the use of these devices.