The U.S. Department of Veterans Affairs reinstated use of intraocular Avastin (bevacizumab, Roche/Genentech) on October 18, according to a National Pharmacy Benefits Management Services bulletin.
This announcement came just weeks after the VA banned ophthalmic Avastin use due to associated safety concerns stemming from several reports of bacteria-tainted injections (see “
VA Halts Intravitreal Use of Avastin,” October).
Because Avastin is not indicated for intraocular injection, compounding pharmacies must repackage the drug into single-dose vials. This process may yield bacterial contamination and subsequent infectious complications (see “ Growing Reports of Bacteria-Tainted Avastin,” September).
Following the conclusion of a Veterans Health Administration National Leadership investigation, agency representatives determined that it was safe to permit VA ophthalmologists to resume intraocular Avastin use in accordance with several safety provisions:
- Using outsourced compounding pharmacies to prepare intravitreal Avastin for use within VA facilities is not permitted.
- VA pharmacies or ophthalmology providers are not permitted to prepare multiple Avastin doses from one vial. If the patient requires bilateral treatment, a separate vial and syringe must be used for each eye.
- Any unused contents remaining in a punctured Avastin vial shall be treated as chemotherapy waste and discarded as such within the eye clinic.
- Quality assurance standards shall be implemented at the local facility level. These standards include reconciliation of both the patient-specific orders for intravitreal Avastin, compliance with the return and disposal of unused Avastin syringes, as well as a review of the patient medical record.
So, what was the underlying reason for the VA’s temporary moratorium on Avastin use, and why was the ban lifted so quickly? “Like all other sites in the U.S. that have experienced endophthalmitis cases associated with the use of compounded Avastin, the VA’s main concern was not the safety of the medication itself but with improper compounding of the chemical,” says a VA-affiliated optometrist who wishes to remain anonymous. “Like the cases of endophthalmitis that have occurred in the private sector, once the appropriate safety standards were addressed at the compounding pharmacies, VA retinologists were permitted to resume use of Avastin without event.”