VTGM buiten de apotheek en toediening medicatie Module 2b Evidence-tabel

Study reference

Study characteristics

Patient characteristics

Intervention

Control

Follow-up

Outcome measures and effect size

Comments

Das, 2015

Type of study: observational study

Setting and country: laboratory, USA

Funding and conflicts of interest: no conflicts of interest.

Not applicable

Six vials of bevacizumab used on multiple patients on a single day and stored thereafter at 4°C in sterile condition for variable length of time were included as the test vials for all the laboratory studies. The six bevacizumab test vials were stored after a single day use.

Each vial was used on an average for 11 patients on a single day within 4 hours.

At the end of all scheduled intravitreal procedures of the day, the vial was packed in a sterile pouch and left in the refrigerator at 4°C. Fifty microliter of bevacizumab from each bottle was withdrawn aseptically and inoculated in four media (5% sheep blood agar, brain heart infusion broth, thioglycolate broth and Sabouraud dextrose agar) and incubated for 7 days.

Following the in vitro results, the institute used single-dose bevacizumab vials for multiple injections for one week in 221 consecutive patients after obtaining written and informed consent. A new vial of bevacizumab was opened on every first working day of the week (Monday) and used till the last working day (Saturday) of the same week.

One new bevacizumab vial was used as a control.

1, 1.5, 3, 3.5, 5.5 and 6 months

Healthcare related infections

a total of 973 injections in 221 consecutive patients (average 4.4 injections per patient).

There was no infection or inflammation noted in any of these eyes at day 1 and on subsequent visits when bevacizumab was stored at 4°C and used for one week.

Contamination of the product

All samples (6 samples stored for 1, 1.5, 3, 3.5, 5.5 and 6 months and 1 control) were negative for bacteria and fungi in culture after 7 days of incubation.

Orneck, 2008

Type of study: observational study

Setting and country: laboratory, USA

Funding and conflicts of interest: no conflicts of interest.

Not applicable

Four groups of vials were used to simulate the storage and use conditions for bevacizumab. Each group contained 11 doses of 0.2 mL of bevacizumab.

In group A, each syringe was packed in a sterile drape and stored in a sterile stainless-steel container.

In group B, all syringes were kept in the same sterile stainless-steel container covered with a drape.

In group C, all syringes were stored in one nonsterile stainless-steel container.

In group D, the material was kept in the vial; each day, a single dose was drawn up with a sterile needle.

All samples were initially drawn up from the same 16 mL vial, using an 18-gauge needle, in the operating room, under sterile conditions, by the principal investigator, and were transferred into 1 mL tuberculin syringes. Each vial was refrigerated at 4°C for 2 weeks until it was used again. Each group contained 11 doses of bevacizumab 0.2 mL. In total, 44 syringes were prepared for microbial examination. Each day for 10 days, one sample from each group was cultured once at 37°C; one sample from each group was left for 15 days. MacConkey agar, blood agar, thioglycollate broth, and Sabouraud medium were used to assess bacterial and fungal growth. Fifty microliters of material were inoculated directly into each plate. All media except Sabouraud agar plates were incubated at 37°C for 48 hours and checked for microbial growth after 24 and 48 hours. The Sabouraud agar plates were incubated at 30°C for up to 7 days and evaluated for growth each day.

Not applicable

7 days

Contamination of the product

all samples were negative for bacterial growth at 24 and 48 hours. The Sabouraud agar analysis indicated no growth of any fungal organism from the contents of the 44 tested syringes for a period of 7 days. There were no differences between groups A, B, C and D (Ornek, 2008).